<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/NCT01721954</url>
  </required_header>
  <id_info>
    <org_study_id>STX0112</org_study_id>
    <nct_id>NCT01721954</nct_id>
  </id_info>
  <brief_title>FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer</brief_title>
  <acronym>FOXFIREGlobal</acronym>
  <official_title>Assessment of Overall Survival of FOLFOX6m Plus SIR-Spheres Microspheres Versus FOLFOX6m Alone as First-line Treatment in Patients With Non-resectable Liver Metastases From Primary Colorectal Carcinoma in a Randomised Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sirtex Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sirtex Medical</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized, multi-center study that will compare the efficacy and safety of&#xD;
      selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard&#xD;
      chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with&#xD;
      non-resectable liver metastases from primary colorectal carcinoma.&#xD;
&#xD;
      Treatment with the biologic agent bevacizumab, if part of the standard of care at&#xD;
      participating institutions, is allowed within this study at the discretion of the&#xD;
      Investigator.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2013</start_date>
  <completion_date type="Actual">February 28, 2017</completion_date>
  <primary_completion_date type="Actual">December 23, 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From date of randomization until the date of death from any cause assessed up 3 yrs 8 months</time_frame>
    <description>OS defined as the time interval between the date of randomization and the date of death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months.</time_frame>
    <description>PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">209</enrollment>
  <condition>Colorectal Cancer Metastatic</condition>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FOLFOX6m</intervention_name>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_label>Experimental Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SIR-Spheres microspheres</intervention_name>
    <arm_group_label>Experimental Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
          -  Unequivocal and measurable CT evidence of liver metastases which are not treatable by&#xD;
             surgical resection or local ablation&#xD;
&#xD;
          -  Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5&#xD;
             lesions total, &lt; 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single&#xD;
             anatomic area (pelvis, abdomen or chest): any number, &lt; 2 cm)&#xD;
&#xD;
          -  All imaging evidence used as part of the screening process must be within 28 days&#xD;
&#xD;
          -  Suitable for either treatment regimen&#xD;
&#xD;
          -  WHO performance status 0-1&#xD;
&#xD;
          -  Adequate hematological, renal and hepatic function&#xD;
&#xD;
          -  Life expectancy of at least 3 months without any active treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of ascites, cirrhosis, portal hypertension, main portal or venous involvement&#xD;
             or thrombosis as determined by clinical or radiologic assessment&#xD;
&#xD;
          -  Previous radiotherapy delivered to the liver&#xD;
&#xD;
          -  Non-malignant disease that would render the patient unsuitable for treatment according&#xD;
             to the protocol&#xD;
&#xD;
          -  Peripheral neuropathy &gt; grade 2 (NCI-CTC)&#xD;
&#xD;
          -  Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin&#xD;
             chemotherapy&#xD;
&#xD;
          -  Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for&#xD;
             colorectal cancer is permitted provided that it was completed more than 6 months&#xD;
             before entry into the study&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Concurrent or prior history of cancer other than adequately treated non-melanoma skin&#xD;
             cancer or carcinoma in situ of the cervix&#xD;
&#xD;
          -  Allergy to contrast media that would preclude angiography of the hepatic arteries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>City of Hope</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Health</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Healthcare</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Illinois Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adventist Midwest Health</name>
      <address>
        <city>Hinsdale</city>
        <state>Illinois</state>
        <zip>60521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spartanburg Regional Healthcare / Gibbs Cancer Center</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Hospital Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mark's Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fletcher Allen Health Care</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Healthcare</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora St. Luke's Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Border Medical Oncology Research Unit</name>
      <address>
        <city>Albury</city>
        <state>New South Wales</state>
        <zip>2640</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gosford Hospital</name>
      <address>
        <city>Gosford</city>
        <state>New South Wales</state>
        <zip>2250</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Medical Day Care Centre</name>
      <address>
        <city>Wollongong</city>
        <state>New South Wales</state>
        <zip>2500</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane Hospital</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gold Coast Health Services District</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hobart Hospital</name>
      <address>
        <city>Hobart</city>
        <state>Tasmania</state>
        <zip>7000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Bentleigh East</city>
        <state>Victoria</state>
        <zip>3165</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Box Hill Hospital</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Hospital</name>
      <address>
        <city>Footscray</city>
        <state>Victoria</state>
        <zip>3011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peninsula Oncology Centre</name>
      <address>
        <city>Frankston</city>
        <state>Victoria</state>
        <zip>3199</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Eastern Hospital</name>
      <address>
        <city>Noble Park</city>
        <state>Victoria</state>
        <zip>3174</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maroondah Hospital</name>
      <address>
        <city>Ringwood East</city>
        <state>Victoria</state>
        <zip>3135</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. John of God Murdoch Hospital</name>
      <address>
        <city>Murdoch</city>
        <state>Western Australia</state>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Charles Gairdner Hospital</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Perth Hospital</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OL Vrouw Ziekenhuis</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Antwerp</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universiteits Ziekenhuis Gent - Dienst Digestieve Oncologie</name>
      <address>
        <city>Gent</city>
        <zip>1K12IE</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Maria Middelaress</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Sart Tilman</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens Cedex 1</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier General de Longjumeau</name>
      <address>
        <city>Clichy Cedex</city>
        <zip>92118</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Beaujon</name>
      <address>
        <city>Clichy Cedex</city>
        <zip>92118</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Albert Michallon - Grenoble</name>
      <address>
        <city>Grenoble Cedex 9</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Europeen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux - Hopital Saint Andre</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers, Pole regional de cancerologie</name>
      <address>
        <city>Poitiers cedex</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Eugene Marquis</name>
      <address>
        <city>Rennes Cedex</city>
        <zip>35042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes Klinikum Neukolln Klinik fur Innere Medizin - Hamatologie und Onkologie</name>
      <address>
        <city>Berlin</city>
        <zip>12351</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SLK-Kliniken Heilbronn GmbH, Klinik fur Radiologie</name>
      <address>
        <city>Heilbronn</city>
        <zip>74078</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stadtisches Klinikum Karlsruheg GMBH Klinik fur Nuklearmedizin</name>
      <address>
        <city>Karlsruhe</city>
        <zip>76133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schwerpunktpraxix fur Hamatologie und Onkologie</name>
      <address>
        <city>Magdeburg</city>
        <zip>39104</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Magdeburg, Klinik fur Radiologie und Nuklearmedizin</name>
      <address>
        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Magdeburg GmbH, Klinik fur Allgemein und Viszeralchirurgie</name>
      <address>
        <city>Magdeburg</city>
        <zip>39130</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Marburg Klinik fur Hamatologie, Onkologie und Immunologie</name>
      <address>
        <city>Marburg</city>
        <zip>35043</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Franziskus Hospital Muenster</name>
      <address>
        <city>Muenster</city>
        <zip>48145</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar der TU Munchen Medizinische Klinik II</name>
      <address>
        <city>Munchen</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universitat Munchen</name>
      <address>
        <city>Munich</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare-Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>91031</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TA Sourasky Medical Center, Oncology Department 6</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center - Governmental Hospital - Oncology Division</name>
      <address>
        <city>Tel Hashomer</city>
        <zip>56261</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Regionale U. Parini</name>
      <address>
        <city>Aosta</city>
        <zip>11100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dipartimento di Oncologia, Ospendali Riuniti di Bergamo</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. die Bologna</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ufficio Sperimentale Cliniche, Oncologia Medica di Carle, Ospendale Santa Croce e Carle di Cuneo</name>
      <address>
        <city>Cuneo</city>
        <zip>12100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.O. Oncologia Medica II, Nuovo Ospendale Santa Chiara, Azienda Ospendaliero Universitaria Pisana, Presidio Ospendaliero di Cisanello</name>
      <address>
        <city>Pisa</city>
        <zip>56124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>136-705</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellington Hospital</name>
      <address>
        <city>Newtown</city>
        <state>Wellington</state>
        <zip>6021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dunedin Hospital</name>
      <address>
        <city>Dunedin</city>
        <zip>9016</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland University</name>
      <address>
        <city>Grafton</city>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Cancer Treatment Service</name>
      <address>
        <city>Palmerston North</city>
        <zip>4414</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Centre Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>169610</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro Majadahonda</name>
      <address>
        <city>Madrid</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>New Zealand</country>
    <country>Portugal</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>van Hazel GA, Heinemann V, Sharma NK, Findlay MP, Ricke J, Peeters M, Perez D, Robinson BA, Strickland AH, Ferguson T, Rodriguez J, Kroning H, Wolf I, Ganju V, Walpole E, Boucher E, Tichler T, Shacham-Shmueli E, Powell A, Eliadis P, Isaacs R, Price D, Moeslein F, Taieb J, Bower G, Gebski V, Van Buskirk M, Cade DN, Thurston K, Gibbs P. SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer. J Clin Oncol. 2016 May 20;34(15):1723-31. doi: 10.1200/JCO.2015.66.1181. Epub 2016 Feb 22. Erratum In: J Clin Oncol. 2016 Nov 20;34(33):4059.</citation>
    <PMID>26903575</PMID>
  </results_reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <results_first_submitted>August 12, 2019</results_first_submitted>
  <results_first_submitted_qc>October 2, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 22, 2019</results_first_posted>
  <last_update_submitted>October 23, 2019</last_update_submitted>
  <last_update_submitted_qc>October 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colon</keyword>
  <keyword>rectum</keyword>
  <keyword>metastatic colorectal cancer</keyword>
  <keyword>liver metastases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Between 01May2013&amp;24Dec2014,209 patients were screened&amp;randomised from 87centres in Australia, Belgium,France, Germany, Israel, Italy, Korea, New Zealand, Portugal, Singapore, Spain,Taiwan &amp;the US. 209 patients randomized in the Intent to treat (ITT) population. 5 patients who did not receive study medication were not included in safety population.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>mFOLFOX6 Plus SIRT</title>
          <description>Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.&#xD;
FOLFOX6m&#xD;
SIR-Spheres microspheres</description>
        </group>
        <group group_id="P2">
          <title>mFOLFOX6 Alone</title>
          <description>Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.&#xD;
FOLFOX6m</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="104"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="69"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>mFOLFOX6 Plus SIRT</title>
          <description>Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.&#xD;
FOLFOX6m&#xD;
SIR-Spheres microspheres</description>
        </group>
        <group group_id="B2">
          <title>mFOLFOX6 Alone</title>
          <description>Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.&#xD;
FOLFOX6m</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="105"/>
            <count group_id="B2" value="104"/>
            <count group_id="B3" value="209"/>
          </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="62.6" spread="11.28"/>
                    <measurement group_id="B2" value="62.4" spread="10.06"/>
                    <measurement group_id="B3" value="62.5" spread="10.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age, Categorical</title>
              <category_list>
                <category>
                  <title>Below 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Greater than or equal to 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="92"/>
                  </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="41"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="124"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="181"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>WHO performance status</title>
          <description>(0) Able to carry out all normal activity without restriction&#xD;
(1) Restricted in physically strenuous activity but ambulatory and able to carry out light work</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Extra-hepatic Disease</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Liver Involvement %</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;=25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tumor volume</title>
          <units>percentage of liver</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.5" spread="17.77"/>
                    <measurement group_id="B2" value="17.9" spread="16.18"/>
                    <measurement group_id="B3" value="18.2" spread="16.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ITT bevacizumab</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="174"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS)</title>
        <description>OS defined as the time interval between the date of randomization and the date of death from any cause.</description>
        <time_frame>From date of randomization until the date of death from any cause assessed up 3 yrs 8 months</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>mFOLFOX6 Plus SIRT</title>
            <description>Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.&#xD;
FOLFOX6m&#xD;
SIR-Spheres microspheres</description>
          </group>
          <group group_id="O2">
            <title>mFOLFOX6 Alone</title>
            <description>Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.&#xD;
FOLFOX6m</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS defined as the time interval between the date of randomization and the date of death from any cause.</description>
          <population>ITT population</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9" lower_limit="23.1" upper_limit="29.0"/>
                    <measurement group_id="O2" value="25.0" lower_limit="22.1" upper_limit="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis tested for the primary efficacy endpoint is overall survival (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is OS time for SIRT/FOLFOX treatment lower to that of FOLFOX.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.43</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival</title>
        <description>PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.</description>
        <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months.</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>mFOLFOX6 Plus SIRT</title>
            <description>Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.&#xD;
FOLFOX6m&#xD;
SIR-Spheres microspheres</description>
          </group>
          <group group_id="O2">
            <title>mFOLFOX6 Alone</title>
            <description>Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.&#xD;
FOLFOX6m</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival</title>
          <description>PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.</description>
          <population>ITT population</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" lower_limit="10.3" upper_limit="14.5"/>
                    <measurement group_id="O2" value="11.2" lower_limit="9.4" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A sample size of at least 209 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 14.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 209. The Null hypothesis is no difference between the treatment arms with respect to PFS.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.75</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From consent until 28 days post last dose of protocol chemotherapy, an average of 3 years 8 months.</time_frame>
      <desc>Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment.&#xD;
Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants.&#xD;
The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.</desc>
      <group_list>
        <group group_id="E1">
          <title>mFOLFOX6 Plus SIRT</title>
          <description>Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.&#xD;
FOLFOX6m&#xD;
SIR-Spheres microspheres</description>
        </group>
        <group group_id="E2">
          <title>mFOLFOX6 Alone</title>
          <description>Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.&#xD;
FOLFOX6m</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 16.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="58" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="64" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Arteriospasm Coronary</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Cardiotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal Detachment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Vitreous Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Anal Fissure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Duodenal Perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Duodenal Ulcer Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Gastric Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Intestinal Perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Large Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Large Intestine Perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Neutropenic Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Small Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Varices Oesophageal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>General Physical Health Deterioration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Mucosal Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Hepatic Cirrhosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Hepatic Failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Portal Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Anal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Campylobacter Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Clostridium Difficile Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Device Related Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Device Related Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Enteritis Infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Enterococcal Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Escherichia Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Escherichia Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Infusion Site Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Infusion Site Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Lung Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Neutropenic Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pelvic Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Peritonitis Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pseudomonal Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Rectal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Skin Bacterial Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arterial Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Stoma Complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Hip Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Intestinal Anastomosis Complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Thermal Burn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>C-Reactive Protein Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>White Blood Cell Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Diabetic Complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Diabetic Ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </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" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Groin Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Muscle Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pain In Extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pathological Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastases To Meninges</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Mental Impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Psychosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Failure Acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Renal Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pneumonia Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Decubitus Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Artery Dissection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Jugular Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Orthostatic Hypotensio</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Peripheral Artery Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Vena Cava Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 16.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="92" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="111" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Lacrimation Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="59" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal Reflux Disease</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Mouth Ulceration</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Rectal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="49" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Mucosal Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight Decreased</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Neutrophil Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Weight Increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Platelet Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Blood Alkaline Phosphatase Increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>White Blood Cell Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Blood Bilirubin Increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Blood Albumin Decreased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="112"/>
              </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" subjects_affected="9" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pain In Extremity</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Muscle Spasms</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Palmar-Plantar Erythrodysaesthesia Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Dry Skin</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="112"/>
              </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>Janet Bell, M.B.A.</name_or_title>
      <organization>Sirtex Medical</organization>
      <phone>+ 888-474-7839 ext 710</phone>
      <email>jbell@sirtex.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/NCT01721954
org study id: STX0112
nct id: NCT01721954
lead sponsor: 
has dmc: Yes
This study is a randomized, multi-center study that will compare the efficacy and safety of
      selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard
      chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with
      non-resectable liver metastases from primary colorectal carcinoma.

      Treatment with the biologic agent bevacizumab, if part of the standard of care at
      participating institutions, is allowed within this study at the discretion of the
      Investigator.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival (OS)
time frame: From date of randomization until the date of death from any cause assessed up 3 yrs 8 months
description: OS defined as the time interval between the date of randomization and the date of death from any cause.
measure: Progression-free Survival
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months.
description: PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.
arm group label: Control Arm
arm group type: Active Comparator
description: Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.
arm group label: Experimental Arm
arm group type: Experimental
description: Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.
intervention type: Drug
intervention name: FOLFOX6m
arm group label: Control Arm
arm group label: Experimental Arm
intervention type: Device
intervention name: SIR-Spheres microspheres
arm group label: Experimental Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Australia
country: Belgium
country: France
country: Germany
country: Israel
country: Italy
country: Korea, Republic of
country: New Zealand
country: Portugal
country: Singapore
country: Spain
country: Taiwan
country: United States
citation: van Hazel GA, Heinemann V, Sharma NK, Findlay MP, Ricke J, Peeters M, Perez D, Robinson BA, Strickland AH, Ferguson T, Rodriguez J, Kroning H, Wolf I, Ganju V, Walpole E, Boucher E, Tichler T, Shacham-Shmueli E, Powell A, Eliadis P, Isaacs R, Price D, Moeslein F, Taieb J, Bower G, Gebski V, Van Buskirk M, Cade DN, Thurston K, Gibbs P. SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer. J Clin Oncol. 2016 May 20;34(15):1723-31. doi: 10.1200/JCO.2015.66.1181. Epub 2016 Feb 22. Erratum In: J Clin Oncol. 2016 Nov 20;34(33):4059.
PMID: 26903575
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: No
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