<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/NCT01672879</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-321-0106</org_study_id>
    <secondary_id>2012-002489-11</secondary_id>
    <nct_id>NCT01672879</nct_id>
  </id_info>
  <brief_title>Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH</brief_title>
  <acronym>NASH</acronym>
  <official_title>A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 (LOXL2), in Subjects With Compensated Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly&#xD;
      referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic&#xD;
      Steatohepatitis (NASH). It will consist of 2 phases:&#xD;
&#xD;
        -  Randomized Double-Blind Phase&#xD;
&#xD;
        -  Open-Label Phase (optional)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">October 29, 2012</start_date>
  <completion_date type="Actual">January 3, 2017</completion_date>
  <primary_completion_date type="Actual">September 26, 2016</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Hepatic Venous Pressure Gradient (HVPG)</measure>
    <time_frame>Baseline to Week 96</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Event-Free Survival (EFS) Using Kaplan-Meier</measure>
    <time_frame>Baseline up to the time of clinical event or last dose date (maximum: 240 weeks in Blinded Phase); which ever occurred first</time_frame>
    <description>Event free survival (EFS) was the primary clinical efficacy endpoint and was assessed by time to first liver-related event or death, whichever occurs first. Liver-related events included any of the following:&#xD;
Liver transplantation&#xD;
Qualification for liver transplantation&#xD;
Model for End-Stage Liver Disease (MELD) ≥ 15&#xD;
Events indicative of hepatic decompensation&#xD;
Esophageal variceal bleeding&#xD;
Ascites&#xD;
Hepatic Encephalopathy&#xD;
≥ 2 point increase in Child Pugh-Turcotte (CPT) score&#xD;
Newly diagnosed varices in a subject without prior varices</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">259</enrollment>
  <condition>Liver Fibrosis Due to NASH</condition>
  <arm_group>
    <arm_group_label>SIM 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the Randomized Double-Blind Phase, participants will receive SIM 200 mg via intravenous infusion every 2 weeks for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 700 mg via intravenous infusion every 2 weeks for up to an additional 240 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SIM 700 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the Randomized Double-Blind Phase, participants will receive SIM 700 mg via intravenous infusion every 2 weeks for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 700 mg via intravenous infusion every 2 weeks for up to an additional 240 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>During the Randomized Double-Blind Phase, participants will receive placebo to match SIM administered via intravenous infusion every 2 weeks for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo to match SIM intravenous infusion over 30 minutes every 2 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SIM</intervention_name>
    <description>Intravenous infusion over 30 minutes every 2 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>SIM 200 mg</arm_group_label>
    <arm_group_label>SIM 700 mg</arm_group_label>
    <other_name>GS-6624</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Adults with cirrhosis of the liver defined as an Ishak fibrosis stage ≥ 5&#xD;
&#xD;
          -  Liver biopsy consistent with NASH or cryptogenic cirrhosis&#xD;
&#xD;
          -  Exclusion of other causes of liver disease including viral hepatitis and alcoholic&#xD;
             liver disease&#xD;
&#xD;
          -  The liver biopsy sample must be determined to be adequate for evaluation by the&#xD;
             Central pathologist&#xD;
&#xD;
          -  Must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 x&#xD;
             the upper limit of the normal range (ULN)&#xD;
&#xD;
          -  Must have serum creatinine &lt; 2.0 mg/dL&#xD;
&#xD;
          -  A negative serum pregnancy test is required for female subjects of childbearing&#xD;
             potential&#xD;
&#xD;
          -  All sexually active female subjects of childbearing potential must agree to use a&#xD;
             protocol recommended method of contraception during heterosexual intercourse&#xD;
             throughout the study and for 90 days following the last dose of study medication&#xD;
&#xD;
          -  Lactating females must agree to discontinue nursing before starting study treatment&#xD;
&#xD;
          -  Male subjects, if not vasectomized, are required to use barrier contraception (condom&#xD;
             plus spermicide) during heterosexual intercourse from the screening through the study&#xD;
             completion and for 90 days following the last dose of study drug&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Any history of hepatic decompensation including ascites, hepatic encephalopathy or&#xD;
             variceal bleeding&#xD;
&#xD;
          -  Weight reduction surgery in the past 5 year&#xD;
&#xD;
          -  Child-Pugh-Turcotte (CPT) score &gt;7; Model for End-Stage Liver Disease (MELD) score &gt;&#xD;
             12 and Body Mass Index (BMI) &lt;18kg/m2&#xD;
&#xD;
          -  Positive for hepatitis C virus (HCV) RNA&#xD;
&#xD;
          -  Positive for HBsAg&#xD;
&#xD;
          -  Alcohol consumption greater than 21oz/week for males or 14oz/week for females&#xD;
&#xD;
          -  Positive urine screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at&#xD;
             screening. Subjects on stable methadone or buprenorphine maintenance treatment for at&#xD;
             least 6 months prior to screening may be included in the study. Subjects with a&#xD;
             positive urine drug screen due to prescription opioid-based medication are eligible if&#xD;
             the prescription and diagnosis are reviewed and approved by the investigator&#xD;
&#xD;
          -  Clinically significant cardiac disease&#xD;
&#xD;
          -  History of malignancy, other than non-melanomatous skin cancer, within 5 years prior&#xD;
             to screening&#xD;
&#xD;
          -  Major surgical procedure within 30 days prior to screening or the presence of an open&#xD;
             wound&#xD;
&#xD;
          -  Known hypersensitivity to the investigation product or any of its formulation&#xD;
             excipients&#xD;
&#xD;
          -  History of bleeding diathesis within 6 months of screening&#xD;
&#xD;
          -  Unavailable for follow-up assessment or concern for subject's compliance with the&#xD;
             protocol procedures;&#xD;
&#xD;
          -  Participation in an investigational trial of a drug or device within 30 days prior to&#xD;
             screening&#xD;
&#xD;
          -  History of solid-organ transplant; poor venous access or requirement for permanent or&#xD;
             semi-permanent central vein catheter such as portacath&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilead Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Liver Centers</name>
      <address>
        <city>Coronado</city>
        <state>California</state>
        <zip>92118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Diego (UCSD)</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco (UCSF)</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado, Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University School of Medicine, Division of Gastroenterology/Hepatology</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Digestive Disease Center</name>
      <address>
        <city>Clive</city>
        <state>Iowa</state>
        <zip>50325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20889</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lahey Clinic</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Michigan</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnnesota Gastroenterology, PA</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis University Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State University Of New York at Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore University Health System</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Case Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Gastroenterology</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist University Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Clinical Research Institute</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brooke Army Medical Center</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke Episcopal Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alamo Clinical Research Associates</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Transplant Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liver Institute of Virginia</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive and Liver Disease Specialists</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bucheon St. Marys Hospital</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 3P4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dalhousie University</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Liver Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6H 3M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Croix Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Saint-Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Pitié-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fonds de Recherche Honoraires</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterologisch-Hepatologisches Zentrum Kiel</name>
      <address>
        <city>Kiel</city>
        <zip>24146</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eugastro Gmbh</name>
      <address>
        <city>Leipzig</city>
        <zip>4129</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Policlinico di Modena</name>
      <address>
        <city>Modena</city>
        <zip>41100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Città della Salute e della Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion De Investigacion</name>
      <address>
        <city>San Juan</city>
        <zip>00927</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vall D´Hebron</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluna</state>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital, Pond Street</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital NHS Trust</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals Queen's Medical Centre</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Sanyal A, Harrison S, Ratziu V, Abdelmalek M, Diehl A, Caldwell S, et al. Changes in fibrosis, but not the NAFLD Activity Score (NAS), are associated with disease progression in patients with nonalcoholic steatohepatitis (NASH) and advanced fibrosis. J Hepatol 2017; 66 (1): S2.</citation>
  </results_reference>
  <results_reference>
    <citation>Sanyal A, Abdelmalek M, Diehl A, Caldwell S, Shiffman M, Ghalib R, et al. Efficacy and safety of simtuzumab for the treatment of nonalcoholic steatohepatitis with bridging fibrosis or cirrhosis: results of two phase 2b, dose-ranging, randomized, placebo-controlled trials. J Hepatol 2017; 66 (1): S54.</citation>
  </results_reference>
  <results_reference>
    <citation>Bosch J, Harrison S, Ratziu V, Shiffman M, Diehl A, Caldwell S, et al. Impact of modest weight reduction on liver histology, portal pressure, and clinical events in patients with compensated cirrhosis due to nonalcoholic steatohepatitis. J Hepatol 2017; 66 (1): S159-S160.</citation>
  </results_reference>
  <results_reference>
    <citation>Sanyal A, Goodman Z, Harrison S, Rockey DC, Diehl AM, Caldwell S, et al. Correlation between the hepatic venous pressure gradient and alpha-smooth muscle actin (SMA) expression in patients with compensated cirrhosis due to nonalcoholic steatohepatitis. J Hepatol 2016; 64 (2): S251.</citation>
  </results_reference>
  <results_reference>
    <citation>Shea PR, Sanyal A, Harrison S, Ratziu V, Loomba R, Caldwell S, et al. PNPLA3 variants confer an increased risk of advanced fibrosis due to non-alcoholic steatohepatitis. J Hepatol 2016; 64 (2): S493.</citation>
  </results_reference>
  <results_reference>
    <citation>Shea PR, Sanyal A, Rockey DC, Loomba R, Diehl AM, Kleinstein SE, et al. Genome-wide association study of clinically significant portal hypertension in patients with nonalcoholic steatohepatitis and advanced fibrosis. J Hepatol 2016; 64 (2): S280.</citation>
  </results_reference>
  <results_reference>
    <citation>Bosch J, Ratziu V, Rockey DC, Ghalib RH, Thuluvath PJ, Shiefke I, et al. Correlation between noninvasive markers of fibrosis and the hepatic venous pressure gradient (HVPG) in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 578A.</citation>
  </results_reference>
  <results_reference>
    <citation>Goodman ZD, Alaparthi L, Monge F, Patel K, Loomba R, Caldwell SH, et al. Correlations between hepatic morphometric collagen content, histologic fibrosis staging, and serum markers in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 906A.</citation>
  </results_reference>
  <results_reference>
    <citation>Harrison SA, Goodman ZD, Ratziu V, Loomba R, Diehl AM, Lawitz E, et al. Serum lysyl oxidase-like-2 (sLOXL2) levels correlate with fibrosis stage in patients with nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 910A.</citation>
  </results_reference>
  <results_reference>
    <citation>Sanyal AJ, Goodman ZD, Abdelmalek MF, Harrison SA, Rockey DC, Diehl AM, et al. Clinical and histologic correlates of the hepatic venous pressure gradient (HVPG) in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 577A.</citation>
  </results_reference>
  <results_reference>
    <citation>Ratziu V, Sanyal AJ, Loomba R, Caldwell SH, Ghalib RH, Torres DM, et al. Characterization of insulin resistance in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 1298A-1299A.</citation>
  </results_reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>March 1, 2019</results_first_submitted>
  <results_first_submitted_qc>March 1, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">March 27, 2019</results_first_posted>
  <disposition_first_submitted>February 23, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>February 23, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 24, 2017</disposition_first_posted>
  <last_update_submitted>March 1, 2019</last_update_submitted>
  <last_update_submitted_qc>March 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NASH</keyword>
  <keyword>cirrhosis</keyword>
  <keyword>Compensated Liver disease</keyword>
  <keyword>Monoclonal antibody</keyword>
  <keyword>LOXL2</keyword>
  <keyword>Simtuzumab</keyword>
  <keyword>Nonalcoholic Steatohepatitis</keyword>
  <keyword>Hepatic venous pressure gradient</keyword>
  <keyword>HVPG</keyword>
  <keyword>NAFLD</keyword>
  <keyword>MRE</keyword>
  <keyword>Liver biopsy</keyword>
  <keyword>Liver fibrosis</keyword>
  <keyword>Ishak</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at study sites in Europe and North America. The first participant was screened on 29 October 2012. The last study visit occurred on 03 January 2017.</recruitment_details>
      <pre_assignment_details>453 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SIM 200 mg</title>
          <description>Blinded Phase: Participants received simtuzumab (SIM) 200 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.&#xD;
Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks.</description>
        </group>
        <group group_id="P2">
          <title>SIM 700 mg</title>
          <description>Blinded Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.&#xD;
Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Blinded Phase: Participants received placebo to match SIM administered via intravenous infusion every 2 weeks for up to 240 weeks.&#xD;
Open-Label Phase: Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Blinded Phase (Up to 240 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
                <participants group_id="P2" count="86"/>
                <participants group_id="P3" count="86"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
                <participants group_id="P2" count="86"/>
                <participants group_id="P3" count="86"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="55"/>
                <participants group_id="P3" count="61"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator's Discretion</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missing</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but Never Treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Met Protocol-Specified Reason(s)</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-Label Phase (Up to 240 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15">Met protocol-specified reason(s) for study discontinuation during Blinded Phase &amp; entered Open-Label</participants>
                <participants group_id="P2" count="17">Met protocol-specified reason(s) for study discontinuation during Blinded Phase &amp; entered Open-Label</participants>
                <participants group_id="P3" count="8">Met protocol-specified reason(s) for study discontinuation during Blinded Phase &amp; entered Open-Label</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator's Discretion</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set included all enrolled participants who were randomized and received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>SIM 200 mg</title>
          <description>Blinded Phase: Participants received SIM 200 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.&#xD;
Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks.</description>
        </group>
        <group group_id="B2">
          <title>SIM 700 mg</title>
          <description>Blinded Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.&#xD;
Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Blinded Phase: Participants received placebo to match SIM administered via intravenous infusion every 2 weeks for up to 240 weeks.&#xD;
Open-Label Phase: Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks.</description>
        </group>
        <group group_id="B4">
          <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="87"/>
            <count group_id="B2" value="86"/>
            <count group_id="B3" value="85"/>
            <count group_id="B4" value="258"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56" spread="7.2"/>
                    <measurement group_id="B2" value="55" spread="7.3"/>
                    <measurement group_id="B3" value="56" spread="7.8"/>
                    <measurement group_id="B4" value="55" spread="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="56"/>
                    <measurement group_id="B4" value="163"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="83"/>
                    <measurement group_id="B4" value="238"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="75"/>
                    <measurement group_id="B4" value="219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="76"/>
                    <measurement group_id="B4" value="211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hepatic Venous Pressure Gradient (HVPG)</title>
          <population>Full Analysis Set included all enrolled participants who were randomized and received at least 1 dose of study drug. Only participants with available baseline data were analyzed.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="85"/>
                    <count group_id="B3" value="84"/>
                    <count group_id="B4" value="256"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.9" spread="5.10"/>
                    <measurement group_id="B2" value="12.8" spread="5.37"/>
                    <measurement group_id="B3" value="13.0" spread="5.25"/>
                    <measurement group_id="B4" value="12.9" spread="5.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hepatic Venous Pressure Gradient (HVPG)</title>
        <time_frame>Baseline to Week 96</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SIM 200 mg</title>
            <description>Blinded Phase: Participants received SIM 200 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.&#xD;
Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SIM 700 mg</title>
            <description>Blinded Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.&#xD;
Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Blinded Phase: Participants received placebo to match SIM administered via intravenous infusion every 2 weeks for up to 240 weeks.&#xD;
Open-Label Phase: Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hepatic Venous Pressure Gradient (HVPG)</title>
          <population>Participants in the Full Analysis Set with available data were analyzed.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="3.76"/>
                    <measurement group_id="O2" value="0.0" spread="4.23"/>
                    <measurement group_id="O3" value="-0.1" spread="4.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in HVPG at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in HVPG at Week 96 contributed to the overall model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in LSMeans [SIM - Placebo]</param_type>
            <param_value>0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>1.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An MMRM with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in HVPG at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in HVPG at Week 96 contributed to the overall model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in LSMeans [SIM - Placebo]</param_type>
            <param_value>0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>1.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Event-Free Survival (EFS) Using Kaplan-Meier</title>
        <description>Event free survival (EFS) was the primary clinical efficacy endpoint and was assessed by time to first liver-related event or death, whichever occurs first. Liver-related events included any of the following:&#xD;
Liver transplantation&#xD;
Qualification for liver transplantation&#xD;
Model for End-Stage Liver Disease (MELD) ≥ 15&#xD;
Events indicative of hepatic decompensation&#xD;
Esophageal variceal bleeding&#xD;
Ascites&#xD;
Hepatic Encephalopathy&#xD;
≥ 2 point increase in Child Pugh-Turcotte (CPT) score&#xD;
Newly diagnosed varices in a subject without prior varices</description>
        <time_frame>Baseline up to the time of clinical event or last dose date (maximum: 240 weeks in Blinded Phase); which ever occurred first</time_frame>
        <population>Participants in the Full Analysis Set were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SIM 200 mg</title>
            <description>Blinded Phase: Participants received SIM 200 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.&#xD;
Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SIM 700 mg</title>
            <description>Blinded Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.&#xD;
Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Blinded Phase: Participants received placebo to match SIM administered via intravenous infusion every 2 weeks for up to 240 weeks.&#xD;
Open-Label Phase: Open-Label Phase: Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Event-Free Survival (EFS) Using Kaplan-Meier</title>
          <description>Event free survival (EFS) was the primary clinical efficacy endpoint and was assessed by time to first liver-related event or death, whichever occurs first. Liver-related events included any of the following:&#xD;
Liver transplantation&#xD;
Qualification for liver transplantation&#xD;
Model for End-Stage Liver Disease (MELD) ≥ 15&#xD;
Events indicative of hepatic decompensation&#xD;
Esophageal variceal bleeding&#xD;
Ascites&#xD;
Hepatic Encephalopathy&#xD;
≥ 2 point increase in Child Pugh-Turcotte (CPT) score&#xD;
Newly diagnosed varices in a subject without prior varices</description>
          <population>Participants in the Full Analysis Set were analyzed.</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="87"/>
                <count group_id="O2" value="86"/>
                <count group_id="O3" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Data was not estimable as more than 50% of participants were censored.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Data was not estimable as more than 50% of participants were censored.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Data was not estimable as more than 50% of participants were censored.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by HVPG category (&lt; 10 mmHg vs ≥ 10 mmHg) and presence or absence of diabetes at baseline.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.41</p_value>
            <method>Stratified log-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by HVPG category (&lt; 10 mmHg vs ≥ 10 mmHg) and presence or absence of diabetes at baseline.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.065</p_value>
            <method>Stratified log-rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to the last dose date plus 30 days (average exposure: SIM 200 mg= 109.3 weeks, SIM 700 mg= 115.9 weeks, Placebo= 120.2 weeks, Open-label SIM 700 mg= 46.2 weeks)</time_frame>
      <desc>Safety Analysis Set included all enrolled participants who were randomized and received at least one dose of study drug and Open-Label Safety Analysis Set included all participants who rolled over into the open-label phase and received at least 1 dose of open-label study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Blinded Phase: SIM 200 mg</title>
          <description>Adverse events recorded in this group occurred during the Blinded Phase. Participants received SIM 200 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Blinded Phase: SIM 700 mg</title>
          <description>Adverse events recorded in this group occurred during the Blinded Phase. Participants received SIM 700 mg administered via intravenous infusion every 2 weeks for up to 240 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Blinded Phase: Placebo</title>
          <description>Adverse events recorded in this group occurred during the Blinded Phase. Participants received placebo to match SIM administered via intravenous infusion every 2 weeks for up to 240 weeks.</description>
        </group>
        <group group_id="E4">
          <title>Open-Label Phase: SIM 700 mg</title>
          <description>All participants who completed the randomized phase through the Week 240 visit, or who had an adjudicated clinical event prior to completing the randomized phase, were offered the opportunity to receive open-label SIM for up to 240 additional weeks. Adverse events recorded in this group occurred during the Open-Label Phase. All participants received fixed-dose open-label SIM 700 mg intravenous infusions every 2 weeks for up to 240 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Bandaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </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="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Basedow's disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hyperparathyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Epiploic appendagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hernial eventration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Oesophageal varices haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Varices oesophageal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Gallbladder polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Haemobilia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Ischaemic hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Bacterial pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Gastroenteritis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Rocky mountain spotted fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Post procedural discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Procedural hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood osmolarity decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Electrocardiogram T wave peaked</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Model for end stage liver disease score abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Model for end stage liver disease score increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </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="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Lactic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </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="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Cervical spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Compartment syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Osteoporotic fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Breast cancer recurrent</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Endometrial cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hepatic neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hodgkin's disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Thyroid cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Cervical myelopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hepatic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Migraine with aura</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Nerve compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Temporal lobe epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol withdrawal syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Drug abuse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Psychiatric decompensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hepatic hydrothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hydrothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Nasal septum deviation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Portopulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Respiratory depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</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="85" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="81" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="83" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="32" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Splenomegaly</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="33" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Portal hypertensive gastropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Varices oesophageal</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Infusion site pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="40"/>
              </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="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hepatomegaly</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Peritonitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="40"/>
              </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="10" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </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="7" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hepatic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Gynaecomastia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </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>After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:&#xD;
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or&#xD;
The study has been completed at all study sites for at least 2 years</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Gilead Clinical Study Information Center</name_or_title>
      <organization>Gilead Sciences</organization>
      <phone>1-833-445-3230 (GILEAD-0)</phone>
      <email>GileadClinicalTrials@gilead.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/NCT01672879
org study id: GS-US-321-0106
secondary id: 2012-002489-11
nct id: NCT01672879
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly
      referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic
      Steatohepatitis (NASH). It will consist of 2 phases:

        -  Randomized Double-Blind Phase

        -  Open-Label Phase (optional)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Hepatic Venous Pressure Gradient (HVPG)
time frame: Baseline to Week 96
measure: Event-Free Survival (EFS) Using Kaplan-Meier
time frame: Baseline up to the time of clinical event or last dose date (maximum: 240 weeks in Blinded Phase); which ever occurred first
description: Event free survival (EFS) was the primary clinical efficacy endpoint and was assessed by time to first liver-related event or death, whichever occurs first. Liver-related events included any of the following:
Liver transplantation
Qualification for liver transplantation
Model for End-Stage Liver Disease (MELD) ≥ 15
Events indicative of hepatic decompensation
Esophageal variceal bleeding
Ascites
Hepatic Encephalopathy
≥ 2 point increase in Child Pugh-Turcotte (CPT) score
Newly diagnosed varices in a subject without prior varices
arm group label: SIM 200 mg
arm group type: Experimental
description: During the Randomized Double-Blind Phase, participants will receive SIM 200 mg via intravenous infusion every 2 weeks for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 700 mg via intravenous infusion every 2 weeks for up to an additional 240 weeks.
arm group label: SIM 700 mg
arm group type: Experimental
description: During the Randomized Double-Blind Phase, participants will receive SIM 700 mg via intravenous infusion every 2 weeks for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 700 mg via intravenous infusion every 2 weeks for up to an additional 240 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: During the Randomized Double-Blind Phase, participants will receive placebo to match SIM administered via intravenous infusion every 2 weeks for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 700 mg administered via intravenous infusion every 2 weeks for up to an additional 240 weeks.
intervention type: Biological
intervention name: Placebo
description: Placebo to match SIM intravenous infusion over 30 minutes every 2 weeks
arm group label: Placebo
intervention type: Biological
intervention name: SIM
description: Intravenous infusion over 30 minutes every 2 weeks
arm group label: Placebo
arm group label: SIM 200 mg
arm group label: SIM 700 mg
other name: GS-6624
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Gilead Study Director
role: Study Director
affiliation: Gilead Sciences
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country: Canada
country: France
country: Germany
country: Italy
country: Puerto Rico
country: Spain
country: United Kingdom
country: United States
citation: Sanyal A, Harrison S, Ratziu V, Abdelmalek M, Diehl A, Caldwell S, et al. Changes in fibrosis, but not the NAFLD Activity Score (NAS), are associated with disease progression in patients with nonalcoholic steatohepatitis (NASH) and advanced fibrosis. J Hepatol 2017; 66 (1): S2.
citation: Sanyal A, Abdelmalek M, Diehl A, Caldwell S, Shiffman M, Ghalib R, et al. Efficacy and safety of simtuzumab for the treatment of nonalcoholic steatohepatitis with bridging fibrosis or cirrhosis: results of two phase 2b, dose-ranging, randomized, placebo-controlled trials. J Hepatol 2017; 66 (1): S54.
citation: Bosch J, Harrison S, Ratziu V, Shiffman M, Diehl A, Caldwell S, et al. Impact of modest weight reduction on liver histology, portal pressure, and clinical events in patients with compensated cirrhosis due to nonalcoholic steatohepatitis. J Hepatol 2017; 66 (1): S159-S160.
citation: Sanyal A, Goodman Z, Harrison S, Rockey DC, Diehl AM, Caldwell S, et al. Correlation between the hepatic venous pressure gradient and alpha-smooth muscle actin (SMA) expression in patients with compensated cirrhosis due to nonalcoholic steatohepatitis. J Hepatol 2016; 64 (2): S251.
citation: Shea PR, Sanyal A, Harrison S, Ratziu V, Loomba R, Caldwell S, et al. PNPLA3 variants confer an increased risk of advanced fibrosis due to non-alcoholic steatohepatitis. J Hepatol 2016; 64 (2): S493.
citation: Shea PR, Sanyal A, Rockey DC, Loomba R, Diehl AM, Kleinstein SE, et al. Genome-wide association study of clinically significant portal hypertension in patients with nonalcoholic steatohepatitis and advanced fibrosis. J Hepatol 2016; 64 (2): S280.
citation: Bosch J, Ratziu V, Rockey DC, Ghalib RH, Thuluvath PJ, Shiefke I, et al. Correlation between noninvasive markers of fibrosis and the hepatic venous pressure gradient (HVPG) in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 578A.
citation: Goodman ZD, Alaparthi L, Monge F, Patel K, Loomba R, Caldwell SH, et al. Correlations between hepatic morphometric collagen content, histologic fibrosis staging, and serum markers in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 906A.
citation: Harrison SA, Goodman ZD, Ratziu V, Loomba R, Diehl AM, Lawitz E, et al. Serum lysyl oxidase-like-2 (sLOXL2) levels correlate with fibrosis stage in patients with nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 910A.
citation: Sanyal AJ, Goodman ZD, Abdelmalek MF, Harrison SA, Rockey DC, Diehl AM, et al. Clinical and histologic correlates of the hepatic venous pressure gradient (HVPG) in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 577A.
citation: Ratziu V, Sanyal AJ, Loomba R, Caldwell SH, Ghalib RH, Torres DM, et al. Characterization of insulin resistance in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 1298A-1299A.
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Fibrosis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 