<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/NCT01696396</url>
  </required_header>
  <id_info>
    <org_study_id>20110232</org_study_id>
    <secondary_id>2012-000529-31</secondary_id>
    <nct_id>NCT01696396</nct_id>
  </id_info>
  <brief_title>Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the efficacy of abrilumab as measured by&#xD;
      the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission&#xD;
      (CDAI &lt; 150) after treatment for 8 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consisted of a 24-week double-blind treatment period, a 108-week open-label&#xD;
      treatment period, and a 2-year safety follow-up period.&#xD;
&#xD;
      Participants who did not reach minimal improvement, or experienced disease worsening after&#xD;
      initial response, had the option to receive open-label abrilumab 210 mg every 3 months (Q3M)&#xD;
      beginning at double-blind period week 12 or after. Not reaching minimal improvement was&#xD;
      defined as not having an improvement in CDAI score of ≥ 70 points from baseline on 2&#xD;
      consecutive visits (at or after week 8) at least 2 weeks apart. Disease worsening after week&#xD;
      8 (or week 12) response was defined as having an increase in CDAI score of ≥ 70 points from&#xD;
      the week 8 (or week 12) CDAI score on 2 consecutive visits at least 2 weeks apart, and a CDAI&#xD;
      score of &gt; 150.&#xD;
&#xD;
      Participants were planned to be randomized in a 2:1:2:1 ratio to SC placebo or abrilumab at&#xD;
      21 mg, 70 mg (on day 1, week 2, week 4, and every 4 weeks thereafter until week 24), or 210&#xD;
      mg (on day 1 followed by placebo in weeks 2 and 4 and every 4 weeks thereafter until week&#xD;
      24), respectively. Due to a consistent discrepancy between the investigational product (IP)&#xD;
      instruction manual (IPIM) description of vial positions and the actual vial positions in the&#xD;
      IP package participants were initially randomized to 3 arms (placebo, 70 mg, and 210 mg) with&#xD;
      a randomization ratio of 3:2:1. The study was temporarily paused while this issue was&#xD;
      investigated. Once the discrepancy was corrected, Protocol Amendment 3 implemented, and&#xD;
      affected participants completed their double-blind treatment period, the study resumed&#xD;
      enrollment and randomization per protocol. Neither the randomization nor study blind was&#xD;
      compromised and therefore the intent-to-treat principle was maintained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2012</start_date>
  <completion_date type="Actual">April 10, 2018</completion_date>
  <primary_completion_date type="Actual">December 26, 2014</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Remission at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>Remission was defined as a Crohn's Disease Activity Index (CDAI) score &lt; 150 at week 8.&#xD;
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Remission at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Remission was defined as a Crohn's Disease Activity Index (CDAI) score &lt; 150. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Response at Week 12</measure>
    <time_frame>Baseline and week 12</time_frame>
    <description>Response was defined as either remission (a CDAI score &lt; 150) or a decrease from baseline in the CDAI score of ≥ 100 points.&#xD;
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Response at Week 8</measure>
    <time_frame>Baseline and week 8</time_frame>
    <description>Response was defined as either remission (a CDAI score &lt; 150) or a decrease from baseline in the CDAI score of ≥ 100 points.&#xD;
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Remission at Both Week 12 and Week 24</measure>
    <time_frame>Week 12 and week 24</time_frame>
    <description>Remission was defined as a Crohn's Disease Activity Index (CDAI) score &lt; 150. Sustained remission was defined as achieving the criteria for remission at both week 12 and week 24.&#xD;
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Remission at Both Week 8 and Week 24</measure>
    <time_frame>Week 8 and week 24</time_frame>
    <description>Remission was defined as a Crohn's Disease Activity Index (CDAI) score &lt; 150. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24.&#xD;
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CDAI Score at Week 12</measure>
    <time_frame>Baseline and week 12</time_frame>
    <description>The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CDAI Score at Week 8</measure>
    <time_frame>Baseline and week 8</time_frame>
    <description>The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">254</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Placebo Q4W/Abrilumab 210 mg Q3M</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.&#xD;
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24.&#xD;
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.&#xD;
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Abrilumab 210 mg/Abrilumab 210 mg Q3M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24.&#xD;
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M)for 108 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abrilumab</intervention_name>
    <description>Administered by subcutaneous injection.</description>
    <arm_group_label>Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M</arm_group_label>
    <arm_group_label>Abrilumab 210 mg/Abrilumab 210 mg Q3M</arm_group_label>
    <arm_group_label>Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M</arm_group_label>
    <arm_group_label>Placebo Q4W/Abrilumab 210 mg Q3M</arm_group_label>
    <other_name>AMG 181</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matching to abrilumab administered by subcutaneous injection</description>
    <arm_group_label>Abrilumab 210 mg/Abrilumab 210 mg Q3M</arm_group_label>
    <arm_group_label>Placebo Q4W/Abrilumab 210 mg Q3M</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6&#xD;
             months prior to baseline&#xD;
&#xD;
          -  Moderately to severely active Crohn's disease defined by a CDAI score ≥ 220 and ≤ 450&#xD;
             at baseline&#xD;
&#xD;
          -  Evidence of active inflammation within 12 weeks prior to baseline&#xD;
&#xD;
          -  Demonstrated an inadequate response to, loss of response to, or intolerance to at&#xD;
             least one of the following agents: Immunomodulators and/or anti-tumor necrosis factor&#xD;
             (TNF) agents or to corticosteroids (non-US sites only).&#xD;
&#xD;
          -  Neurological exam free of clinically significant, unexplained signs or symptoms during&#xD;
             screening and no clinically significant change prior to randomization&#xD;
&#xD;
          -  Subject has no known history of active tuberculosis and has a negative test for&#xD;
             tuberculosis during screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Short bowel syndrome&#xD;
&#xD;
          -  Stricture with obstructive symptoms within 3 months&#xD;
&#xD;
          -  Bowel surgery within 12 weeks prior baseline, or has planned bowel surgery within 24&#xD;
             weeks from baseline&#xD;
&#xD;
          -  Ileostomy and/or colostomy&#xD;
&#xD;
          -  Any gastric or intestinal pouch&#xD;
&#xD;
          -  Evidence of an infected abscess&#xD;
&#xD;
          -  Bowel perforation or evidence of non-inflammatory obstruction during the 6 months&#xD;
             prior to baseline&#xD;
&#xD;
          -  Stool positive for C. difficile toxin at screening&#xD;
&#xD;
          -  Any uncontrolled or clinically significant systemic disease&#xD;
&#xD;
          -  Known to have tested positive for hepatitis B virus surface antigen, hepatitis C virus&#xD;
             antibody, or human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Any underlying condition that predisposes subject to infections&#xD;
&#xD;
          -  Subject has malignancy (other than resected cutaneous basal or cutaneous squamous cell&#xD;
             carcinoma, or treated in situ cervical cancer considered cured) within 5 years of&#xD;
             baseline&#xD;
&#xD;
          -  Received an anti-TNF agent, cyclosporine, mycophenolate mofetil, sirolimus&#xD;
             (rapamycin), thalidomide, tacrolimus, topical (rectal) aminosalicylic acid (eg,&#xD;
             mesalamine) or topical (rectal) steroids, intravenous or intramuscular corticosteroids&#xD;
             within protocol-specified time periods.&#xD;
&#xD;
          -  Any prior exposure to antagonists of integrins or integrin ligands (eg, natalizumab,&#xD;
             efalizumab, or vedolizumab), rituximab, or TNF kinoid immunotherapies, AMG 181, or any&#xD;
             form of cell-based transplantation&#xD;
&#xD;
          -  Received treatment of infection with intravenous (within 30 days of baseline) or oral&#xD;
             (within 14 days prior to baseline) antibiotics, antivirals, or antifungals&#xD;
&#xD;
          -  Significant laboratory abnormalities&#xD;
&#xD;
          -  Pregnant or breast feeding&#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>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <zip>36305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Goodyear</city>
        <state>Arizona</state>
        <zip>85395</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sanford</city>
        <state>Florida</state>
        <zip>32771</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chesterfield</city>
        <state>Michigan</state>
        <zip>48047</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mexico</city>
        <state>Missouri</state>
        <zip>65265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St Veit an der Glan</city>
        <zip>9300</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wien</city>
        <zip>1050</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bonheiden</city>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <zip>P3E 1H5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 0W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 12</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha 4</city>
        <zip>140 21</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha 4</city>
        <zip>140 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha 5</city>
        <zip>150 06</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha 7</city>
        <zip>170 04</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Usti nad Labem</city>
        <zip>401 13</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Køge</city>
        <zip>4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Århus C</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Amiens Cedex 1</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Caen Cedex 9</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Clichy</city>
        <zip>92110</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nice Cedex 3</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Paris Cedex 10</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Paris cedex 12</city>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pessac Cedex</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vandoeuvre les Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hamburg</city>
        <zip>20148</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leipzig</city>
        <zip>04105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Minden</city>
        <zip>32423</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Stuttgart</city>
        <zip>70376</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bekescsaba</city>
        <zip>5600</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1088</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1125</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miskolc</city>
        <zip>3526</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Szekszard</city>
        <zip>7100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Breda</city>
        <zip>4818 CK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leiden</city>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <zip>B18 7QH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Coventry</city>
        <zip>CV2 2DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <zip>NW1 2BU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Manchester</city>
        <zip>M8 5RB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Norwich</city>
        <zip>NR4 7UY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Torquay</city>
        <zip>TQ2 7AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Netherlands</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <reference>
    <citation>Dummer R, Hoeller C, Gruter IP, Michielin O. Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. Cancer Immunol Immunother. 2017 Jun;66(6):683-695. doi: 10.1007/s00262-017-1967-1. Epub 2017 Feb 25.</citation>
    <PMID>28238174</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <results_first_submitted>April 8, 2019</results_first_submitted>
  <results_first_submitted_qc>May 24, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 27, 2019</results_first_posted>
  <disposition_first_submitted>December 19, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>December 19, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">January 25, 2016</disposition_first_posted>
  <last_update_submitted>May 24, 2019</last_update_submitted>
  <last_update_submitted_qc>May 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IBD, Crohn's Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at 84 centers in Canada, European Union, and the United States. Participants were enrolled from 04 December 2012 to 30 September 2014.&#xD;
The study consisted of a 24-week double-blind treatment period, a 108-week open-label treatment period, and a safety follow-up period.</recruitment_details>
      <pre_assignment_details>Participants were to be randomly assigned in a 2:1:2:1 ratio to 1 of 4 treatment groups. Due to a misalignment error, some participants were erroneously assigned to incorrect treatment resulting in a final randomization ratio different from that originally stipulated in the protocol.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo/Abrilumab 210 mg Q3M</title>
          <description>Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.&#xD;
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M</title>
          <description>Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24.&#xD;
During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M</title>
          <description>Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.&#xD;
During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks.</description>
        </group>
        <group group_id="P4">
          <title>Abrilumab 210 mg/Abrilumab 210 mg Q3M</title>
          <description>Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24.&#xD;
During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="85"/>
                <participants group_id="P4" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="98"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="84"/>
                <participants group_id="P4" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Entered Open-label Period</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="75"/>
                <participants group_id="P4" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="59"/>
                <participants group_id="P4" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="26"/>
                <participants group_id="P4" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Decision by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
        </group>
        <group group_id="B2">
          <title>Abrilumab 21 mg Q4W</title>
          <description>Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.</description>
        </group>
        <group group_id="B3">
          <title>Abrilumab 70 mg Q4W</title>
          <description>Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
        </group>
        <group group_id="B4">
          <title>Abrilumab 210 mg</title>
          <description>Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="85"/>
            <count group_id="B4" value="42"/>
            <count group_id="B5" value="254"/>
          </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="100"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="42"/>
                    <count group_id="B5" value="254"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.2" spread="11.2"/>
                    <measurement group_id="B2" value="38.9" spread="14.2"/>
                    <measurement group_id="B3" value="35.6" spread="11.8"/>
                    <measurement group_id="B4" value="36.5" spread="9.4"/>
                    <measurement group_id="B5" value="36.4" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="42"/>
                    <count group_id="B5" value="254"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>18 - 64 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="85"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="253"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </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="100"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="42"/>
                    <count group_id="B5" value="254"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="144"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="34"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="42"/>
                    <count group_id="B5" value="254"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="85"/>
                    <measurement group_id="B4" value="41"/>
                    <measurement group_id="B5" value="252"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</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="100"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="42"/>
                    <count group_id="B5" value="254"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="82"/>
                    <measurement group_id="B4" value="40"/>
                    <measurement group_id="B5" value="245"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Any Prior Anti-Tumor Necrosis Factor (TNF) Use</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="100"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="42"/>
                    <count group_id="B5" value="254"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="67"/>
                    <measurement group_id="B4" value="33"/>
                    <measurement group_id="B5" value="201"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Enrollment Prior to Protocol Amendment 3</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="100"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="42"/>
                    <count group_id="B5" value="254"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="56"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Crohn's Diease</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="100"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="85"/>
                    <count group_id="B4" value="42"/>
                    <count group_id="B5" value="254"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.07" spread="8.33"/>
                    <measurement group_id="B2" value="12.58" spread="9.55"/>
                    <measurement group_id="B3" value="10.69" spread="7.75"/>
                    <measurement group_id="B4" value="11.31" spread="7.54"/>
                    <measurement group_id="B5" value="11.15" spread="8.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Crohn's Disease Activity Index (CDAI) Score</title>
          <description>The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity. Patients with scores of &gt; 450 are considered to have very severe disease.</description>
          <population>Participants with available data</population>
          <units>units on a scale</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="99"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="84"/>
                    <count group_id="B4" value="42"/>
                    <count group_id="B5" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="303.8" spread="63.2"/>
                    <measurement group_id="B2" value="310.0" spread="83.5"/>
                    <measurement group_id="B3" value="314.0" spread="60.4"/>
                    <measurement group_id="B4" value="319.3" spread="67.5"/>
                    <measurement group_id="B5" value="310.5" spread="65.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Remission at Week 8</title>
        <description>Remission was defined as a Crohn's Disease Activity Index (CDAI) score &lt; 150 at week 8.&#xD;
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).</description>
        <time_frame>Week 8</time_frame>
        <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted remission rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 8 were counted as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Abrilumab 21 mg Q4W</title>
            <description>Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Abrilumab 70 mg Q4W</title>
            <description>Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Abrilumab 210 mg</title>
            <description>Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Remission at Week 8</title>
          <description>Remission was defined as a Crohn's Disease Activity Index (CDAI) score &lt; 150 at week 8.&#xD;
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).</description>
          <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted remission rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 8 were counted as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unadjusted remission rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3"/>
                    <measurement group_id="O2" value="23.1"/>
                    <measurement group_id="O3" value="14.3"/>
                    <measurement group_id="O4" value="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted remission rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8"/>
                    <measurement group_id="O2" value="23.1"/>
                    <measurement group_id="O3" value="14.4"/>
                    <measurement group_id="O4" value="21.9"/>
                  </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>Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The study was powered for formal statistical testing of the abrilumab 70 mg group. The primary and key secondary endpoints were tested under a sequential framework of statistical hypotheses, each with 2-sided significance level of 0.10 for the treatment effect of abrilumab 70 mg compared with placebo.</non_inferiority_desc>
            <p_value>0.76</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.15</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.54</ci_lower_limit>
            <ci_upper_limit>2.44</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in Adjusted Remission Rates</param_type>
            <param_value>1.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.9</ci_lower_limit>
            <ci_upper_limit>8.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.22</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.91</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>4.57</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <param_type>Difference in Adjusted Remission Rates</param_type>
            <param_value>9.1</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.6</ci_lower_limit>
            <ci_upper_limit>19.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.25</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.05</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>5.73</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <param_type>Difference in Adjusted Remission Rates</param_type>
            <param_value>10.3</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.8</ci_lower_limit>
            <ci_upper_limit>22.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Remission at Week 12</title>
        <description>Remission was defined as a Crohn's Disease Activity Index (CDAI) score &lt; 150. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).</description>
        <time_frame>Week 12</time_frame>
        <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted remission rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 12 were counted as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Abrilumab 21 mg Q4W</title>
            <description>Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Abrilumab 70 mg Q4W</title>
            <description>Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Abrilumab 210 mg</title>
            <description>Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Remission at Week 12</title>
          <description>Remission was defined as a Crohn's Disease Activity Index (CDAI) score &lt; 150. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).</description>
          <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted remission rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 12 were counted as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unadjusted remission rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1"/>
                    <measurement group_id="O2" value="33.3"/>
                    <measurement group_id="O3" value="25.3"/>
                    <measurement group_id="O4" value="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted remission rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.1"/>
                    <measurement group_id="O2" value="43.8"/>
                    <measurement group_id="O3" value="31.0"/>
                    <measurement group_id="O4" value="34.8"/>
                  </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>Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.16</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.78</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>3.53</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in Adjusted Remission Rates</param_type>
            <param_value>10.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.8</ci_lower_limit>
            <ci_upper_limit>21.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.13</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.12</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.93</ci_lower_limit>
            <ci_upper_limit>4.84</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <param_type>Difference in Adjusted Remission Rates</param_type>
            <param_value>14.7</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.1</ci_lower_limit>
            <ci_upper_limit>27.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.056</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.10</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.17</ci_lower_limit>
            <ci_upper_limit>8.20</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <param_type>Difference in Adjusted Remission Rates</param_type>
            <param_value>23.7</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.8</ci_lower_limit>
            <ci_upper_limit>39.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Response at Week 12</title>
        <description>Response was defined as either remission (a CDAI score &lt; 150) or a decrease from baseline in the CDAI score of ≥ 100 points.&#xD;
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate).</description>
        <time_frame>Baseline and week 12</time_frame>
        <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted response rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 12 were counted as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Abrilumab 21 mg Q4W</title>
            <description>Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Abrilumab 70 mg Q4W</title>
            <description>Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Abrilumab 210 mg</title>
            <description>Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Response at Week 12</title>
          <description>Response was defined as either remission (a CDAI score &lt; 150) or a decrease from baseline in the CDAI score of ≥ 100 points.&#xD;
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate).</description>
          <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted response rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 12 were counted as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unadjusted response rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7"/>
                    <measurement group_id="O2" value="41.7"/>
                    <measurement group_id="O3" value="45.3"/>
                    <measurement group_id="O4" value="43.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted response rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.3"/>
                    <measurement group_id="O2" value="50.4"/>
                    <measurement group_id="O3" value="55.1"/>
                    <measurement group_id="O4" value="50.9"/>
                  </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>Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.021</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.25</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.27</ci_lower_limit>
            <ci_upper_limit>4.01</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in Adjusted Response Rates</param_type>
            <param_value>19.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.8</ci_lower_limit>
            <ci_upper_limit>31.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.14</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.90</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>3.87</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <param_type>Difference in Adjusted Response Rates</param_type>
            <param_value>15.7</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.3</ci_lower_limit>
            <ci_upper_limit>29.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.23</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.87</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>4.39</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <param_type>Difference in Adjusted Response Rates</param_type>
            <param_value>15.1</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.4</ci_lower_limit>
            <ci_upper_limit>31.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Response at Week 8</title>
        <description>Response was defined as either remission (a CDAI score &lt; 150) or a decrease from baseline in the CDAI score of ≥ 100 points.&#xD;
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate).</description>
        <time_frame>Baseline and week 8</time_frame>
        <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted response rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 8 were counted as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Abrilumab 21 mg Q4W</title>
            <description>Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Abrilumab 70 mg Q4W</title>
            <description>Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Abrilumab 210 mg</title>
            <description>Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Response at Week 8</title>
          <description>Response was defined as either remission (a CDAI score &lt; 150) or a decrease from baseline in the CDAI score of ≥ 100 points.&#xD;
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate).</description>
          <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted response rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 8 were counted as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unadjusted response rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.4"/>
                    <measurement group_id="O2" value="33.3"/>
                    <measurement group_id="O3" value="42.9"/>
                    <measurement group_id="O4" value="30.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted response rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.6"/>
                    <measurement group_id="O2" value="33.8"/>
                    <measurement group_id="O3" value="46.6"/>
                    <measurement group_id="O4" value="32.6"/>
                  </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>Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.047</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.98</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.13</ci_lower_limit>
            <ci_upper_limit>3.47</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in Adjusted Response Rates</param_type>
            <param_value>16.0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.4</ci_lower_limit>
            <ci_upper_limit>27.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.84</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.09</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.52</ci_lower_limit>
            <ci_upper_limit>2.29</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <param_type>Difference in Adjusted Response Rates</param_type>
            <param_value>1.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.2</ci_lower_limit>
            <ci_upper_limit>15.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.78</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.15</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>2.72</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <param_type>Difference in Adjusted Response Rates</param_type>
            <param_value>3.1</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.4</ci_lower_limit>
            <ci_upper_limit>18.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Remission at Both Week 12 and Week 24</title>
        <description>Remission was defined as a Crohn's Disease Activity Index (CDAI) score &lt; 150. Sustained remission was defined as achieving the criteria for remission at both week 12 and week 24.&#xD;
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).</description>
        <time_frame>Week 12 and week 24</time_frame>
        <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted sustained remission rates were calculated using non-responder imputation, where participants with missing CDAI scores at week 12 or week 24 were counted as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Abrilumab 21 mg Q4W</title>
            <description>Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Abrilumab 70 mg Q4W</title>
            <description>Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Abrilumab 210 mg</title>
            <description>Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Remission at Both Week 12 and Week 24</title>
          <description>Remission was defined as a Crohn's Disease Activity Index (CDAI) score &lt; 150. Sustained remission was defined as achieving the criteria for remission at both week 12 and week 24.&#xD;
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).</description>
          <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted sustained remission rates were calculated using non-responder imputation, where participants with missing CDAI scores at week 12 or week 24 were counted as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unadjusted remission rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2"/>
                    <measurement group_id="O2" value="19.2"/>
                    <measurement group_id="O3" value="11.9"/>
                    <measurement group_id="O4" value="17.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted remission rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0"/>
                    <measurement group_id="O2" value="25.0"/>
                    <measurement group_id="O3" value="14.0"/>
                    <measurement group_id="O4" value="21.7"/>
                  </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>Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.34</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.65</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>3.91</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in Adjusted Remission Rates</param_type>
            <param_value>5.0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.9</ci_lower_limit>
            <ci_upper_limit>11.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.078</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.82</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.07</ci_lower_limit>
            <ci_upper_limit>7.41</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <param_type>Difference in Adjusted Remission Rates</param_type>
            <param_value>12.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>22.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.083</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.37</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.07</ci_lower_limit>
            <ci_upper_limit>10.66</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <param_type>Difference in Adjusted Remission Rates</param_type>
            <param_value>16.0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>28.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Remission at Both Week 8 and Week 24</title>
        <description>Remission was defined as a Crohn's Disease Activity Index (CDAI) score &lt; 150. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24.&#xD;
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).</description>
        <time_frame>Week 8 and week 24</time_frame>
        <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted sustained remission rates were calculated using non-responder imputation, where participants with missing CDAI scores at week 8 or week 24 were counted as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Abrilumab 21 mg Q4W</title>
            <description>Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Abrilumab 70 mg Q4W</title>
            <description>Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Abrilumab 210 mg</title>
            <description>Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Remission at Both Week 8 and Week 24</title>
          <description>Remission was defined as a Crohn's Disease Activity Index (CDAI) score &lt; 150. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24.&#xD;
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.&#xD;
The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).</description>
          <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted sustained remission rates were calculated using non-responder imputation, where participants with missing CDAI scores at week 8 or week 24 were counted as non-responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unadjusted remission rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="15.4"/>
                    <measurement group_id="O3" value="9.5"/>
                    <measurement group_id="O4" value="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted remission rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9"/>
                    <measurement group_id="O2" value="14.3"/>
                    <measurement group_id="O3" value="8.7"/>
                    <measurement group_id="O4" value="12.7"/>
                  </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>Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.47</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.52</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.59</ci_lower_limit>
            <ci_upper_limit>3.93</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in Adjusted Remission Rates</param_type>
            <param_value>2.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.7</ci_lower_limit>
            <ci_upper_limit>8.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.21</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.32</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>6.98</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <param_type>Difference in Adjusted Remission Rates</param_type>
            <param_value>6.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.3</ci_lower_limit>
            <ci_upper_limit>14.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.21</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total CDAI score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.66</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>9.45</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <param_type>Difference in Adjusted Remission Rates</param_type>
            <param_value>8.4</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.0</ci_lower_limit>
            <ci_upper_limit>17.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CDAI Score at Week 12</title>
        <description>The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.</description>
        <time_frame>Baseline and week 12</time_frame>
        <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Missing data were handled using the inverse probability weighting (IPW) method.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Abrilumab 21 mg Q4W</title>
            <description>Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Abrilumab 70 mg Q4W</title>
            <description>Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Abrilumab 210 mg</title>
            <description>Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CDAI Score at Week 12</title>
          <description>The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.</description>
          <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Missing data were handled using the inverse probability weighting (IPW) method.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-55.32" spread="11.41"/>
                    <measurement group_id="O2" value="-92.16" spread="21.85"/>
                    <measurement group_id="O3" value="-97.41" spread="12.92"/>
                    <measurement group_id="O4" value="-96.11" spread="22.78"/>
                  </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>Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <method>IPW GEE Model</method>
            <method_desc>Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.</method_desc>
            <param_type>LS Mean Treatment Difference</param_type>
            <param_value>-42.09</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-67.3</ci_lower_limit>
            <ci_upper_limit>-16.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.095</p_value>
            <method>IPW GEE Model</method>
            <method_desc>Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.</method_desc>
            <param_type>LS Mean Treatment Difference</param_type>
            <param_value>-40.79</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-81.5</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.11</p_value>
            <method>IPW GEE Model</method>
            <method_desc>Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.</method_desc>
            <param_type>LS Mean Treatment Difference</param_type>
            <param_value>-36.84</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-74.3</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CDAI Score at Week 8</title>
        <description>The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.</description>
        <time_frame>Baseline and week 8</time_frame>
        <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Missing data were handled using the inverse probability weighting (IPW) method.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Abrilumab 21 mg Q4W</title>
            <description>Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Abrilumab 70 mg Q4W</title>
            <description>Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Abrilumab 210 mg</title>
            <description>Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CDAI Score at Week 8</title>
          <description>The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.</description>
          <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Missing data were handled using the inverse probability weighting (IPW) method.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="84"/>
                <count group_id="O4" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-64.05" spread="9.62"/>
                    <measurement group_id="O2" value="-80.42" spread="20.86"/>
                    <measurement group_id="O3" value="-91.52" spread="11.78"/>
                    <measurement group_id="O4" value="-87.64" spread="19.89"/>
                  </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>Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.045</p_value>
            <method>IPW GEE Model</method>
            <method_desc>Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.</method_desc>
            <param_type>LS Mean Treatment Difference</param_type>
            <param_value>-27.47</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-50.0</ci_lower_limit>
            <ci_upper_limit>-4.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.27</p_value>
            <method>IPW GEE Model</method>
            <method_desc>Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.</method_desc>
            <param_type>LS Mean Treatment Difference</param_type>
            <param_value>-23.59</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-58.7</ci_lower_limit>
            <ci_upper_limit>11.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Analysis was not part of the formal testing</non_inferiority_desc>
            <p_value>0.45</p_value>
            <method>IPW GEE Model</method>
            <method_desc>Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.</method_desc>
            <param_type>LS Mean Treatment Difference</param_type>
            <param_value>-16.37</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-51.8</ci_lower_limit>
            <ci_upper_limit>19.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).</time_frame>
      <desc>One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods.&#xD;
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.</desc>
      <group_list>
        <group group_id="E1">
          <title>DB Period: Placebo</title>
          <description>Participants received placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind (DB) treatment period.</description>
        </group>
        <group group_id="E2">
          <title>DB Period: Abrilumab 21 mg Q4W</title>
          <description>Participants received 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
        </group>
        <group group_id="E3">
          <title>DB Period: Abrilumab 70 mg Q4W</title>
          <description>Participants received 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
        </group>
        <group group_id="E4">
          <title>DB Period: Abrilumab 210 mg</title>
          <description>Participants received a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.</description>
        </group>
        <group group_id="E5">
          <title>OL Period: Placebo/Abrilumab 210 mg Q3M</title>
          <description>Participants who received placebo during the double-blind treatment period received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks during the open-label (OL) treatment period.</description>
        </group>
        <group group_id="E6">
          <title>OL Period: Abrilumab 21 mg Q4W/210 mg Q3M</title>
          <description>During the open-label period, participants who received 21 mg abrilumab Q4W during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks.</description>
        </group>
        <group group_id="E7">
          <title>OL Period: Abrilumab 70 mg Q4W/210 mg Q3M</title>
          <description>Participants who received 70 mg abrilumab Q4W during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks during the open-label period.</description>
        </group>
        <group group_id="E8">
          <title>Period: Abrilumab 210 mg/210 mg Q3M</title>
          <description>Participants who received 210 mg abrilumab during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks during the open-label period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</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="14" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="24" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="19" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="12" subjects_at_risk="37"/>
              </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="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </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="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Enterocolonic fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ileal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Biliary colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal wall abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abscess intestinal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Appendicitis perforated</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>External ear cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Intrauterine infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Necrotising fasciitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pelvic abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Perineal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pneumonia parainfluenzae viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Psoas abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Retroperitoneal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tubo-ovarian abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vulval abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anastomotic leak</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Intestinal anastomosis complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </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="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Chronic myeloid leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical dysplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Aborted pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cholecystectomy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ileocolectomy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Scoliosis surgery</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.1</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="61" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="48" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="27" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="61" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="55" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="28" subjects_at_risk="37"/>
              </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="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="14" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="12" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oral discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="12" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="14" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Psoas abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood iron decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Clostridium test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </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="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Magnesium deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vitamin B12 deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Zinc deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </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="10" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nervous system disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Female sterilisation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="37"/>
              </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>The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Amgen Inc.</organization>
      <phone>866-572-6436</phone>
      <email>medinfo@amgen.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/NCT01696396
org study id: 20110232
secondary id: 2012-000529-31
nct id: NCT01696396
lead sponsor: 
has dmc: Yes
The primary objective of this study is to evaluate the efficacy of abrilumab as measured by
      the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission
      (CDAI < 150) after treatment for 8 weeks.
The study consisted of a 24-week double-blind treatment period, a 108-week open-label
      treatment period, and a 2-year safety follow-up period.

      Participants who did not reach minimal improvement, or experienced disease worsening after
      initial response, had the option to receive open-label abrilumab 210 mg every 3 months (Q3M)
      beginning at double-blind period week 12 or after. Not reaching minimal improvement was
      defined as not having an improvement in CDAI score of ≥ 70 points from baseline on 2
      consecutive visits (at or after week 8) at least 2 weeks apart. Disease worsening after week
      8 (or week 12) response was defined as having an increase in CDAI score of ≥ 70 points from
      the week 8 (or week 12) CDAI score on 2 consecutive visits at least 2 weeks apart, and a CDAI
      score of > 150.

      Participants were planned to be randomized in a 2:1:2:1 ratio to SC placebo or abrilumab at
      21 mg, 70 mg (on day 1, week 2, week 4, and every 4 weeks thereafter until week 24), or 210
      mg (on day 1 followed by placebo in weeks 2 and 4 and every 4 weeks thereafter until week
      24), respectively. Due to a consistent discrepancy between the investigational product (IP)
      instruction manual (IPIM) description of vial positions and the actual vial positions in the
      IP package participants were initially randomized to 3 arms (placebo, 70 mg, and 210 mg) with
      a randomization ratio of 3:2:1. The study was temporarily paused while this issue was
      investigated. Once the discrepancy was corrected, Protocol Amendment 3 implemented, and
      affected participants completed their double-blind treatment period, the study resumed
      enrollment and randomization per protocol. Neither the randomization nor study blind was
      compromised and therefore the intent-to-treat principle was maintained.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Percentage of Participants With Remission at Week 8
time frame: Week 8
description: Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150 at week 8.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
measure: Percentage of Participants With Remission at Week 12
time frame: Week 12
description: Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
measure: Percentage of Participants With Response at Week 12
time frame: Baseline and week 12
description: Response was defined as either remission (a CDAI score < 150) or a decrease from baseline in the CDAI score of ≥ 100 points.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate).
measure: Percentage of Participants With Response at Week 8
time frame: Baseline and week 8
description: Response was defined as either remission (a CDAI score < 150) or a decrease from baseline in the CDAI score of ≥ 100 points.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate).
measure: Percentage of Participants With Sustained Remission at Both Week 12 and Week 24
time frame: Week 12 and week 24
description: Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150. Sustained remission was defined as achieving the criteria for remission at both week 12 and week 24.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
measure: Percentage of Participants With Sustained Remission at Both Week 8 and Week 24
time frame: Week 8 and week 24
description: Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
measure: Change From Baseline in CDAI Score at Week 12
time frame: Baseline and week 12
description: The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
measure: Change From Baseline in CDAI Score at Week 8
time frame: Baseline and week 8
description: The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
arm group label: Placebo Q4W/Abrilumab 210 mg Q3M
arm group type: Placebo Comparator
description: Participants received placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.
arm group label: Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M
arm group type: Experimental
description: Participants received 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.
arm group label: Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M
arm group type: Experimental
description: Participants received 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.
arm group label: Abrilumab 210 mg/Abrilumab 210 mg Q3M
arm group type: Experimental
description: Participants received a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M)for 108 weeks.
intervention type: Drug
intervention name: Abrilumab
description: Administered by subcutaneous injection.
arm group label: Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M
arm group label: Abrilumab 210 mg/Abrilumab 210 mg Q3M
arm group label: Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M
arm group label: Placebo Q4W/Abrilumab 210 mg Q3M
other name: AMG 181
intervention type: Drug
intervention name: Placebo
description: Placebo matching to abrilumab administered by subcutaneous injection
arm group label: Abrilumab 210 mg/Abrilumab 210 mg Q3M
arm group label: Placebo Q4W/Abrilumab 210 mg Q3M
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Belgium
country: Canada
country: Czechia
country: Denmark
country: France
country: Germany
country: Hungary
country: Netherlands
country: Switzerland
country: United Kingdom
country: United States
country: Czech Republic
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
citation: Dummer R, Hoeller C, Gruter IP, Michielin O. Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. Cancer Immunol Immunother. 2017 Jun;66(6):683-695. doi: 10.1007/s00262-017-1967-1. Epub 2017 Feb 25.
PMID: 28238174
responsible party type: Sponsor
mesh term: Crohn Disease
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 