<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/NCT02186561</url>
  </required_header>
  <id_info>
    <org_study_id>NV-PED-07</org_study_id>
    <nct_id>NCT02186561</nct_id>
    <nct_alias>NCT02178007</nct_alias>
  </id_info>
  <brief_title>Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device</brief_title>
  <acronym>PREMIER</acronym>
  <official_title>Prospective Study on Embolization of Intracranial Aneurysms With the Pipeline™ Device (PREMIER)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Neurovascular Clinical Affairs</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Neurovascular Clinical Affairs</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device&#xD;
      in the treatment of unruptured, wide-neck intracranial aneurysms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2014</start_date>
  <completion_date type="Actual">December 13, 2018</completion_date>
  <primary_completion_date type="Actual">November 18, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Percentage of Participants With the Occurrence of Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 12-Months Post Procedure</measure>
    <time_frame>Up to 12 Months Post Procedure</time_frame>
    <description>The primary safety endpoint was defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Missing data for subjects who failed to complete the 12- month post-procedure evaluation without any evidence of a major stroke in the territory supplied by the treated artery or neurological death were imputed in the analysis using multiple imputation. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Percentage of Participants With Complete Aneurysm Occlusion (Defined as Raymond Roy Grade 1) Without Significant Parent Artery Stenosis (≤ 50%) or Retreatment of the Target Aneurysm at 12-Months Post-Procedure</measure>
    <time_frame>Up to 12 Months Post Procedure</time_frame>
    <description>The definitions for the three components of the primary effectiveness endpoint were: 1) retreatment, defined as all retreatment procedures occurring between the index procedure and 1 Year post-procedure; 2) complete aneurysm occlusion based on Core Laboratory review of 1-year images and 3) significant parent artery stenosis, based on Core Laboratory review of 1-year images. The Raymond-Roy Grading scale is used for judging intracranial aneurysm (IA) endosaccular embolization success. Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac.&#xD;
Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With a Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 30-days Post Procedure Due to Procedural Complications</measure>
    <time_frame>Up to 30 days, Post Procedure</time_frame>
    <description>Major Stroke is defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Neurological death is any subject death due to neurologic reasons.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage &gt; 30 Days Post-Procedure</measure>
    <time_frame>&gt; 30 days, Post Procedure</time_frame>
    <description>For the purpose of this protocol, delayed intracerebral hemorrhage was defined as hemorrhage within the fixed vault of the cranium (skull) occurring greater than 30 days post-procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With Successfully Deployed Investigational Device</measure>
    <time_frame>Index Procedure</time_frame>
    <description>The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">197</enrollment>
  <condition>Intracranial Aneurysm</condition>
  <arm_group>
    <arm_group_label>Pipeline™ Embolization Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treatment with Pipeline™ Embolization Device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device</intervention_name>
    <arm_group_label>Pipeline™ Embolization Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject has provided written informed consent using the IRB/EC-approved consent form&#xD;
             and agrees to comply with protocol requirements.&#xD;
&#xD;
          2. Age 22-80 years.&#xD;
&#xD;
          3. Subject has a target intracranial aneurysm (IA) located in the:&#xD;
&#xD;
               1. Internal carotid artery (up to the carotid terminus) OR&#xD;
&#xD;
               2. Vertebral artery segment up to and including the posterior inferior cerebellar&#xD;
                  artery&#xD;
&#xD;
          4. Subject has a target IA that is ≤ 12 mm.&#xD;
&#xD;
          5. Subject has a target IA that has a parent vessel with diameter 1.5-5.0 mm&#xD;
             distal/proximal to the target IA.&#xD;
&#xD;
          6. Subject has a target IA with an aneurysm neck ≥ 4mm or a dome to neck ratio ≤ 1.5.&#xD;
&#xD;
          7. Subject has a pre-procedure PRU value between 60-200.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has received an intracranial implant (e.g. coils) in the area of the target IA&#xD;
             within the past 12 weeks.&#xD;
&#xD;
          2. Subarachnoid hemorrhage in the past 30 days.&#xD;
&#xD;
          3. Subject with anatomy not appropriate for endovascular treatment due to severe&#xD;
             intracranial vessel tortuosity or stenosis determined from baseline or pre-procedure&#xD;
             imaging, or a history of intracranial vasospasm not responsive to medical therapy.&#xD;
&#xD;
          4. Major surgery in the last 30 days.&#xD;
&#xD;
          5. History of irreversible bleeding disorder and/or subject presents with signs of active&#xD;
             bleeding.&#xD;
&#xD;
          6. Any known contraindication to treatment with the Pipeline™ device, including:&#xD;
&#xD;
               1. Stent is in place in the parent artery at the target IA location&#xD;
&#xD;
               2. Contraindication to dual antiplatelet therapy&#xD;
&#xD;
               3. Relative contraindication to angiography (e.g., serum creatinine &gt;2.5 mg/dL,&#xD;
                  allergy to contrast that cannot be medically controlled).&#xD;
&#xD;
               4. Known severe allergy to platinum or cobalt/chromium alloys.&#xD;
&#xD;
               5. Evidence of active infection at the time of treatment (e.g., fever with&#xD;
                  temperature &gt;38°C and/or WBC &gt;1.5 109/L).&#xD;
&#xD;
          7. The Investigator determines that the health of the subject or the validity of the&#xD;
             study outcomes (e.g., high risk of neurologic events, worsening of clinical condition&#xD;
             in the last 30 days) may be compromised by the subject's enrollment.&#xD;
&#xD;
          8. Pregnant or breast-feeding women or women who wish to become pregnant during the&#xD;
             length of study participation.&#xD;
&#xD;
          9. Participating in another clinical trial during the follow-up period that could&#xD;
             confound the treatment or outcomes of this investigation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo Hanel, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baptist Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radiology Imaging Associates</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Medical Center Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Emory Clinic</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</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>Baptist Physicians Lexington</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts University Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Memorial Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaleida Health/University of Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</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>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Health Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Hospital and Clinics</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Western Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>April 4, 2019</results_first_submitted>
  <results_first_submitted_qc>April 29, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 21, 2019</results_first_posted>
  <disposition_first_submitted>March 7, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>March 7, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 9, 2018</disposition_first_posted>
  <last_update_submitted>December 17, 2019</last_update_submitted>
  <last_update_submitted_qc>December 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intracranial aneurysm</keyword>
  <keyword>brain aneurysm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No, there is not a plan to make IPD available.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 24, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT02186561/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>PREMIER</title>
          <description>The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Enrollment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="197"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did Not Meet Inclusion Criteria</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Enrollment Cap Reached</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Insurance Denial</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Subjects Implanted With Device</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>30-Day Post Index Procedure Visit</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="140"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>180- Day Post Index Procedure Visit</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="134"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>1- Year Post Index Procedure Visit</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="139"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>2 - Year Post Index Procedure Visit</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="134"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>3 - Year Post Index Procedure Visit</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to Treat Population was defined as all enrolled participants in whom deployment of the Investigational device was attempted.</population>
      <group_list>
        <group group_id="B1">
          <title>PREMIER</title>
          <description>The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="141"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.6" spread="11.3"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="115"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Percentage of Participants With the Occurrence of Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 12-Months Post Procedure</title>
        <description>The primary safety endpoint was defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Missing data for subjects who failed to complete the 12- month post-procedure evaluation without any evidence of a major stroke in the territory supplied by the treated artery or neurological death were imputed in the analysis using multiple imputation. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.</description>
        <time_frame>Up to 12 Months Post Procedure</time_frame>
        <population>Participants enrolled and implanted with the Investigational Device (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>PREMIER</title>
            <description>The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.</description>
          </group>
        </group_list>
        <measure>
          <title>The Percentage of Participants With the Occurrence of Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 12-Months Post Procedure</title>
          <description>The primary safety endpoint was defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Missing data for subjects who failed to complete the 12- month post-procedure evaluation without any evidence of a major stroke in the territory supplied by the treated artery or neurological death were imputed in the analysis using multiple imputation. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.</description>
          <population>Participants enrolled and implanted with the Investigational Device (ITT)</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="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Percentage of Participants With Complete Aneurysm Occlusion (Defined as Raymond Roy Grade 1) Without Significant Parent Artery Stenosis (≤ 50%) or Retreatment of the Target Aneurysm at 12-Months Post-Procedure</title>
        <description>The definitions for the three components of the primary effectiveness endpoint were: 1) retreatment, defined as all retreatment procedures occurring between the index procedure and 1 Year post-procedure; 2) complete aneurysm occlusion based on Core Laboratory review of 1-year images and 3) significant parent artery stenosis, based on Core Laboratory review of 1-year images. The Raymond-Roy Grading scale is used for judging intracranial aneurysm (IA) endosaccular embolization success. Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac.&#xD;
Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.</description>
        <time_frame>Up to 12 Months Post Procedure</time_frame>
        <population>Participants Treated with Investigational Device that Completed the 12 Month Visit Imaging</population>
        <group_list>
          <group group_id="O1">
            <title>PREMIER</title>
            <description>The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.</description>
          </group>
        </group_list>
        <measure>
          <title>The Percentage of Participants With Complete Aneurysm Occlusion (Defined as Raymond Roy Grade 1) Without Significant Parent Artery Stenosis (≤ 50%) or Retreatment of the Target Aneurysm at 12-Months Post-Procedure</title>
          <description>The definitions for the three components of the primary effectiveness endpoint were: 1) retreatment, defined as all retreatment procedures occurring between the index procedure and 1 Year post-procedure; 2) complete aneurysm occlusion based on Core Laboratory review of 1-year images and 3) significant parent artery stenosis, based on Core Laboratory review of 1-year images. The Raymond-Roy Grading scale is used for judging intracranial aneurysm (IA) endosaccular embolization success. Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac.&#xD;
Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.</description>
          <population>Participants Treated with Investigational Device that Completed the 12 Month Visit Imaging</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="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With a Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 30-days Post Procedure Due to Procedural Complications</title>
        <description>Major Stroke is defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Neurological death is any subject death due to neurologic reasons.</description>
        <time_frame>Up to 30 days, Post Procedure</time_frame>
        <population>Participants Treated with the Investigational Device that Completed the 30 Day Visit</population>
        <group_list>
          <group group_id="O1">
            <title>PREMIER</title>
            <description>The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With a Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 30-days Post Procedure Due to Procedural Complications</title>
          <description>Major Stroke is defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Neurological death is any subject death due to neurologic reasons.</description>
          <population>Participants Treated with the Investigational Device that Completed the 30 Day Visit</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="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage &gt; 30 Days Post-Procedure</title>
        <description>For the purpose of this protocol, delayed intracerebral hemorrhage was defined as hemorrhage within the fixed vault of the cranium (skull) occurring greater than 30 days post-procedure.</description>
        <time_frame>&gt; 30 days, Post Procedure</time_frame>
        <population>ParticipantsTreated with the Investigational Device that Completed the 30 Day Visit</population>
        <group_list>
          <group group_id="O1">
            <title>PREMIER</title>
            <description>The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage &gt; 30 Days Post-Procedure</title>
          <description>For the purpose of this protocol, delayed intracerebral hemorrhage was defined as hemorrhage within the fixed vault of the cranium (skull) occurring greater than 30 days post-procedure.</description>
          <population>ParticipantsTreated with the Investigational Device that Completed the 30 Day Visit</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With Successfully Deployed Investigational Device</title>
        <description>The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site.</description>
        <time_frame>Index Procedure</time_frame>
        <population>Participants Enrolled who Underwent the Index Procedure</population>
        <group_list>
          <group group_id="O1">
            <title>PREMIER</title>
            <description>The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Successfully Deployed Investigational Device</title>
          <description>The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site.</description>
          <population>Participants Enrolled who Underwent the Index Procedure</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="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected from the point of consent through year 3</time_frame>
      <desc>The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated.&#xD;
Adjudicable events met the following criteria:&#xD;
All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events)&#xD;
All Device Related Adverse Events&#xD;
All Procedure Related Adverse Events&#xD;
All Serious Adverse Events (SAE's)</desc>
      <group_list>
        <group group_id="E1">
          <title>CEC Adjudicated Adverse Events Through 1-Year</title>
          <description>Participants who received the Investigational Device followed through 1 Year</description>
        </group>
        <group group_id="E2">
          <title>CEC Adjudicated Adverse Events Through 2-Year</title>
          <description>Participants who received the Investigational Device followed through 2 Year</description>
        </group>
        <group group_id="E3">
          <title>CEC Adjudicated Adverse Events Through 3-Year</title>
          <description>Participants who received the Investigational Device followed through 3 Year</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.0)</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="1" subjects_at_risk="141"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="141"/>
                <counts group_id="E2" subjects_affected="49" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="60" subjects_at_risk="141"/>
              </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="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Lymphatic Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision Blurred</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </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="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Peritoneal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Gastritis Erosive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Thrombosis in Device</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Portal vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Colonic abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary Aspergillosis Allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Patella Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Procedural hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Vascular Graft Occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Tibia Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Compartment syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Basal Cell Carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Meningioma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid Artery Dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Cerebral Haemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="141"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Cerebral Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="141"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="141"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis relapse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Myasthenia Gravis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Loss of Consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Suicide Attempt</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Suicidal Ideation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Renal failure chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </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="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Ovarian cyst ruptured</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Ovarian Cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Stevens-Johnson Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Aneurysm repair</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="141"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="141"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Coronary Arterial Stent Insertion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Operation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Medical Device Removal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Hypertensive Crisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Vascular Occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Malignant Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Vascular Occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (17.0)</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="107" subjects_at_risk="141"/>
                <counts group_id="E2" subjects_affected="112" subjects_at_risk="141"/>
                <counts group_id="E3" subjects_affected="112" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhagic Diathesis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Lymphoid tissue hyperplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Amaurosis Fugax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Blepharospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Conjunctival Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Photopsia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="141"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="141"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="141"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="141"/>
                <counts group_id="E3" events="17" subjects_affected="17" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Vitreous detachment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Vitreous floaters</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="141"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="141"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Gastrointestinal inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Catheter site haematoma</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="141"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="141"/>
                <counts group_id="E3" events="13" subjects_affected="13" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Catheter site haemorrhage</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="141"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="141"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="141"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="141"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Local swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Catheter Site Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Periorbital Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Modified Rankin Score Decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypervolaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Spinal Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="141"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Carpal Tunnel Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Cerebral vasoconstriction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="141"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="141"/>
                <counts group_id="E3" events="12" subjects_affected="9" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="35" subjects_affected="33" subjects_at_risk="141"/>
                <counts group_id="E2" events="38" subjects_affected="34" subjects_at_risk="141"/>
                <counts group_id="E3" events="44" subjects_affected="38" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Intracranial Artery Dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Ischaemic Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Muscle spasticity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="141"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="141"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Radiculitis Lumbosacral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Sensory Disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Subarachnoid Heamorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="141"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Transient Ischaemic Attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Visual field defect</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Cognitive Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Monoplegia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Dysphemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="141"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="141"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="28" subjects_affected="28" subjects_at_risk="141"/>
                <counts group_id="E2" events="29" subjects_affected="29" subjects_at_risk="141"/>
                <counts group_id="E3" events="29" subjects_affected="29" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Swelling Face</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arterial stenosis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="141"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="141"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Vasospasm</sub_title>
                <counts group_id="E1" events="29" subjects_affected="28" subjects_at_risk="141"/>
                <counts group_id="E2" events="29" subjects_affected="28" subjects_at_risk="141"/>
                <counts group_id="E3" events="31" subjects_affected="29" subjects_at_risk="141"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="141"/>
              </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 NOT 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>Senior Project Manager, Clinical Project Management</name_or_title>
      <organization>Medtronic Neurovascular, Clinical Affairs</organization>
      <phone>949-680-1274</phone>
      <email>darren.j.lacour@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/NCT02186561
org study id: NV-PED-07
nct id: NCT02186561
nct alias: NCT02178007
lead sponsor: 
has dmc: Yes
is fda regulated device: Yes
The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device
      in the treatment of unruptured, wide-neck intracranial aneurysms.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Percentage of Participants With the Occurrence of Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 12-Months Post Procedure
time frame: Up to 12 Months Post Procedure
description: The primary safety endpoint was defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Missing data for subjects who failed to complete the 12- month post-procedure evaluation without any evidence of a major stroke in the territory supplied by the treated artery or neurological death were imputed in the analysis using multiple imputation. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.
measure: The Percentage of Participants With Complete Aneurysm Occlusion (Defined as Raymond Roy Grade 1) Without Significant Parent Artery Stenosis (≤ 50%) or Retreatment of the Target Aneurysm at 12-Months Post-Procedure
time frame: Up to 12 Months Post Procedure
description: The definitions for the three components of the primary effectiveness endpoint were: 1) retreatment, defined as all retreatment procedures occurring between the index procedure and 1 Year post-procedure; 2) complete aneurysm occlusion based on Core Laboratory review of 1-year images and 3) significant parent artery stenosis, based on Core Laboratory review of 1-year images. The Raymond-Roy Grading scale is used for judging intracranial aneurysm (IA) endosaccular embolization success. Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac.
Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.
measure: The Number of Participants With a Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 30-days Post Procedure Due to Procedural Complications
time frame: Up to 30 days, Post Procedure
description: Major Stroke is defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Neurological death is any subject death due to neurologic reasons.
measure: The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure
time frame: > 30 days, Post Procedure
description: For the purpose of this protocol, delayed intracerebral hemorrhage was defined as hemorrhage within the fixed vault of the cranium (skull) occurring greater than 30 days post-procedure.
measure: The Number of Participants With Successfully Deployed Investigational Device
time frame: Index Procedure
description: The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site.
arm group label: Pipeline™ Embolization Device
arm group type: Experimental
description: treatment with Pipeline™ Embolization Device
intervention type: Device
intervention name: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device
arm group label: Pipeline™ Embolization Device
criteria: 
gender: All
minimum age: 22 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ricardo Hanel, M.D.
role: Principal Investigator
affiliation: Baptist Medical Center
facility: 
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Intracranial Aneurysm
mesh term: Aneurysm
sharing ipd: No
ipd description: No, there is not a plan to make IPD available.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 