<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/NCT01694485</url>
  </required_header>
  <id_info>
    <org_study_id>20110166</org_study_id>
    <secondary_id>2011-005251-13</secondary_id>
    <nct_id>NCT01694485</nct_id>
  </id_info>
  <brief_title>Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis</brief_title>
  <official_title>A Randomized, Double Blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Ulcerative Colitis</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 effect of abrilumab on induction of&#xD;
      remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as&#xD;
      assessed by a total Mayo Score ≤ 2 points, with no individual subscore &gt; 1 point.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consisted of a 24-week double-blind, placebo-controlled treatment period followed&#xD;
      by an open-label period of approximately 108 weeks. Participants were eligible to enter the&#xD;
      open-label period of the study early if they did not achieve a response at week 8 and had an&#xD;
      inadequate response at week 12 or later or if they experienced disease worsening after&#xD;
      achieving response and/or remission at week 8. Failure to achieve response at week 8 was&#xD;
      defined as failure to achieve a decrease from baseline in total Mayo Score ≥ 3 points and ≥&#xD;
      30% decrease from baseline. Inadequate response at week 12 or later was defined as failure to&#xD;
      achieve a 2-point decrease and 25% improvement in partial Mayo Score compared with screening&#xD;
      and minimum partial Mayo Score ≥ 5 points. Disease worsening was defined as an increase in&#xD;
      partial Mayo Score ≥ 3 points from the week 8 value and minimum partial Mayo Score ≥ 5 points&#xD;
      with recto-sigmoidoscopy sub-score ≥ 2.&#xD;
&#xD;
      Participants were planned to be randomized in a 2:1:2:2:2 ratio to placebo or abrilumab at 7&#xD;
      mg, 21 mg, 70 mg (on day 1, week 2, week 4, and every 4 weeks thereafter until week 24), or&#xD;
      210 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 4:3:2. 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">November 16, 2012</start_date>
  <completion_date type="Actual">April 10, 2018</completion_date>
  <primary_completion_date type="Actual">July 13, 2015</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 total Mayo Score ≤ 2 points, with no individual subscore &gt; 1 point.&#xD;
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.&#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 total Mayo Score (adjusted remission rate).</description>
  </primary_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 by a decrease from baseline in the total Mayo Score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore ≥ 1 point or an absolute rectal bleeding subscore = 0 or 1.&#xD;
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment), each graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, ranging from 0 to 12 points. Higher scores represent more severe disease.&#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 total Mayo Score (adjusted response rate).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Mucosal Healing at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>Mucosal healing was defined using the rectosigmoidoscopy subscore of Mayo assessment as absolute subscore for rectosigmoidoscopy of 0 or 1.&#xD;
Flexible rectosigmoidoscopy was performed as part of the Mayo assessment, graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status.&#xD;
The healing rate (percentage of participants with mucosal healing) was calculated based on observed data (unadjusted healing 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 rectosigmoidoscopy score (adjusted healing rate).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Remission at Week 8 and Week 24</measure>
    <time_frame>Week 8 and week 24</time_frame>
    <description>Remission was defined as a total Mayo Score ≤ 2 points, with no individual subscore &gt; 1 point. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24.&#xD;
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment), each graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher scores represent more severe disease status. The total Mayo Score is the sum of the four item scores, with a and ranges from 0 to 12 points. Higher scores represent more severe disease.&#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 total Mayo Score (adjusted remission rate).</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">359</enrollment>
  <condition>Ulcerative Colitis</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 7 mg Q4W/Abrilumab 210 mg Q3M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 7 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 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 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>Biological</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 7 mg Q4W/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;
          -  Diagnosis of ulcerative colitis (UC) established ≥ 3 months before baseline by&#xD;
             clinical and endoscopic evidence and corroborated by a histopathology report.&#xD;
&#xD;
          -  Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with a&#xD;
             centrally read rectosigmoidoscopy score ≥2 prior to baseline&#xD;
&#xD;
          -  Inadequate response to, loss of response to, or intolerance to at least one of the&#xD;
             following treatments:&#xD;
&#xD;
               -  Immunomodulators&#xD;
&#xD;
               -  Anti-TNF agents&#xD;
&#xD;
               -  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;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disease limited to the rectum (ie, within 10 cm of the anal verge)&#xD;
&#xD;
          -  Toxic megacolon&#xD;
&#xD;
          -  Crohn's Disease&#xD;
&#xD;
          -  History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch,&#xD;
             Koch pouch, or ileostomy for UC&#xD;
&#xD;
          -  Planned bowel surgery within 24 weeks from baseline&#xD;
&#xD;
          -  Stool positive for C. Difficile toxin at screening&#xD;
&#xD;
          -  History of gastrointestinal surgery within 8 weeks of baseline&#xD;
&#xD;
          -  Primary Sclerosing Cholangitis&#xD;
&#xD;
          -  Any uncontrolled or clinically significant systemic disease&#xD;
&#xD;
          -  Condition or disease that, in the opinion of the investigator would pose a risk to&#xD;
             subject safety or interfere with study evaluation, procedures or completion.&#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;
          -  Underlying condition that predisposes subject to infections (eg, uncontrolled&#xD;
             diabetes; history of splenectomy)&#xD;
&#xD;
          -  Known history of drug or alcohol abuse within 1 year of screening&#xD;
&#xD;
          -  Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma,&#xD;
             or treated in situ cervical cancer considered cured) within 5 years of screening visit&#xD;
             (if a malignancy occurred &gt; 5 years ago, subject is eligible with documentation of&#xD;
             disease free state since treatment)&#xD;
&#xD;
          -  Immunosuppressive therapy with either cyclosporine A, tacrolimus, or mycophenolate&#xD;
             mofetil, within 1 month prior to baseline&#xD;
&#xD;
          -  Prior exposure to anti tumor necrosis factor (TNF) agents, within 2 months, or 5 times&#xD;
             the respective elimination half life (whichever is longer) prior to baseline&#xD;
&#xD;
          -  Any prior exposure to vedolizumab, rituximab, efalizumab, natalizumab&#xD;
&#xD;
          -  Use of topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal)&#xD;
             steroids within 2 weeks prior to baseline&#xD;
&#xD;
          -  Use of intravenous or intramuscular corticosteroids within 2 weeks prior to screening&#xD;
             and during screening&#xD;
&#xD;
          -  Previously treated with AMG 181&#xD;
&#xD;
          -  Received any type of live attenuated vaccine &lt; 1 month prior to baseline or is&#xD;
             planning to receive any such live attenuated vaccine over the course of the study&#xD;
&#xD;
          -  Treatment of infection with intravenous (within 30 days of baseline) or oral (within&#xD;
             14 days prior to baseline) antibiotics, antivirals, or antifungals&#xD;
&#xD;
          -  Abnormal laboratory results at screening&#xD;
&#xD;
          -  Any other laboratory abnormality, which, in the opinion of the investigator, will&#xD;
             prevent the subject from completing the study or will interfere with the&#xD;
             interpretation of the study results&#xD;
&#xD;
          -  Currently enrolled in another investigational device or drug study, or less than 30&#xD;
             days since ending another investigational device or drug study(s), or receiving other&#xD;
             investigational agent(s)&#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>Scottsdale</city>
        <state>Arizona</state>
        <zip>85260</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>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lone Tree</city>
        <state>Colorado</state>
        <zip>80124</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>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</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>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hammond</city>
        <state>Louisiana</state>
        <zip>70403</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>Great Neck</city>
        <state>New York</state>
        <zip>11021</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>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</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>Seattle</city>
        <state>Washington</state>
        <zip>98185</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bankstown</city>
        <state>New South Wales</state>
        <zip>2200</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Concord</city>
        <state>New South Wales</state>
        <zip>2139</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</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>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>Bruxelles</city>
        <zip>1000</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>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N1</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>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 2K5</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>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 5G2</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>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X5</zip>
        <country>Canada</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 12</zip>
        <country>Czechia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha 4</city>
        <zip>140 59</zip>
        <country>Czechia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha 7</city>
        <zip>170 04</zip>
        <country>Czechia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Usti nad Labem</city>
        <zip>401 13</zip>
        <country>Czechia</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Køge</city>
        <zip>4600</zip>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Århus C</city>
        <zip>8000</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tallinn</city>
        <zip>10117</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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      <name>Research Site</name>
      <address>
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        <zip>80054</zip>
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  <location>
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      <name>Research Site</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nice Cedex 3</city>
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  <location>
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      <name>Research Site</name>
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  <location>
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  <location>
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      <name>Research Site</name>
      <address>
        <city>Vandoeuvre les Nancy</city>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
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      <address>
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      <name>Research Site</name>
      <address>
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  <location>
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      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Larissa</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bekescsaba</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1125</zip>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Debrecen</city>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miskolc</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miskolc</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pecs</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Szeged</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bologna</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Firenze</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
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      <name>Research Site</name>
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      <name>Research Site</name>
      <address>
        <city>Riga</city>
        <zip>1002</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Riga</city>
        <zip>LV-1005</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Breda</city>
        <zip>4818 CK</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leiden</city>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 CE</zip>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oslo</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tromsø</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bialystok</city>
        <zip>15-950</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bydgoszcz</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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      <address>
        <city>Warszawa</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nizhny Novgorod</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Samara</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St.-Petrsburg</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Stavropol</city>
        <zip>355017</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
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  </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>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Blackpool</city>
        <zip>FY3 8NR</zip>
        <country>United Kingdom</country>
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    </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>Derby</city>
        <zip>DE22 3NE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</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_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Latvia</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Russian Federation</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>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 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>March 18, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>March 18, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">April 15, 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>Ulcerative Colitis, IBD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at 92 centers located in North America, Europe, and Australia from 16 November 2012 to 11 May 2015.&#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 2:1:2:2:2 ratio to 1 of 5 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 7 mg Q4W/Abrilumab 210 mg Q3M</title>
          <description>Participants randomized to receive 7 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 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 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 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="P5">
          <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="117"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="40"/>
                <participants group_id="P4" count="100"/>
                <participants group_id="P5" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="40"/>
                <participants group_id="P4" count="98"/>
                <participants group_id="P5" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Week 8 Assessment</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="38"/>
                <participants group_id="P4" count="94"/>
                <participants group_id="P5" count="76"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Entered Open-label Period</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="36"/>
                <participants group_id="P4" count="88"/>
                <participants group_id="P5" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="27"/>
                <participants group_id="P4" count="62"/>
                <participants group_id="P5" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="38"/>
                <participants group_id="P5" count="25"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="25"/>
                <participants group_id="P5" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
              </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="6"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" 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 7 mg Q4W</title>
          <description>Participants randomized to receive 7 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="B3">
          <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 thereafter until week 24 during the double-blind treatment period.</description>
        </group>
        <group group_id="B4">
          <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="B5">
          <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="B6">
          <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="117"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="40"/>
            <count group_id="B4" value="100"/>
            <count group_id="B5" value="80"/>
            <count group_id="B6" value="359"/>
          </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="117"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="100"/>
                    <count group_id="B5" value="80"/>
                    <count group_id="B6" value="359"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.0" spread="13.3"/>
                    <measurement group_id="B2" value="42.0" spread="12.4"/>
                    <measurement group_id="B3" value="38.3" spread="11.6"/>
                    <measurement group_id="B4" value="39.3" spread="12.2"/>
                    <measurement group_id="B5" value="39.8" spread="12.0"/>
                    <measurement group_id="B6" value="40.0" spread="12.5"/>
                  </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="117"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="100"/>
                    <count group_id="B5" value="80"/>
                    <count group_id="B6" value="359"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>18 - 64 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="113"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="99"/>
                    <measurement group_id="B5" value="80"/>
                    <measurement group_id="B6" value="354"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="5"/>
                  </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="117"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="100"/>
                    <count group_id="B5" value="80"/>
                    <count group_id="B6" value="359"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="32"/>
                    <measurement group_id="B6" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="68"/>
                    <measurement group_id="B5" value="48"/>
                    <measurement group_id="B6" value="239"/>
                  </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="117"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="100"/>
                    <count group_id="B5" value="80"/>
                    <count group_id="B6" value="359"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="113"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="100"/>
                    <measurement group_id="B5" value="77"/>
                    <measurement group_id="B6" value="350"/>
                  </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 group_id="B6" 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="117"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="100"/>
                    <count group_id="B5" value="80"/>
                    <count group_id="B6" value="359"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="89"/>
                    <measurement group_id="B5" value="78"/>
                    <measurement group_id="B6" value="335"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="8"/>
                  </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="117"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="100"/>
                    <count group_id="B5" value="80"/>
                    <count group_id="B6" value="359"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="56"/>
                    <measurement group_id="B5" value="39"/>
                    <measurement group_id="B6" value="180"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="44"/>
                    <measurement group_id="B5" value="41"/>
                    <measurement group_id="B6" value="179"/>
                  </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="117"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="100"/>
                    <count group_id="B5" value="80"/>
                    <count group_id="B6" value="359"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="58"/>
                    <measurement group_id="B5" value="38"/>
                    <measurement group_id="B6" value="172"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="42"/>
                    <measurement group_id="B6" value="187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Ulcerative Colitis</title>
          <population>Participants with available data</population>
          <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="116"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="100"/>
                    <count group_id="B5" value="80"/>
                    <count group_id="B6" value="358"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.83" spread="5.58"/>
                    <measurement group_id="B2" value="9.07" spread="6.57"/>
                    <measurement group_id="B3" value="7.05" spread="5.39"/>
                    <measurement group_id="B4" value="9.39" spread="7.25"/>
                    <measurement group_id="B5" value="9.44" spread="7.88"/>
                    <measurement group_id="B6" value="8.62" spread="6.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Mayo Score</title>
          <description>The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.</description>
          <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="117"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                    <count group_id="B4" value="100"/>
                    <count group_id="B5" value="80"/>
                    <count group_id="B6" value="359"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.9" spread="1.5"/>
                    <measurement group_id="B2" value="8.1" spread="1.4"/>
                    <measurement group_id="B3" value="8.6" spread="1.7"/>
                    <measurement group_id="B4" value="9.0" spread="1.5"/>
                    <measurement group_id="B5" value="9.1" spread="1.4"/>
                    <measurement group_id="B6" value="8.9" spread="1.5"/>
                  </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 total Mayo Score ≤ 2 points, with no individual subscore &gt; 1 point.&#xD;
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.&#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 total Mayo 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 Mayo 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 7 mg Q4W</title>
            <description>Participants randomized to receive 7 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="O3">
            <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 thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <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="O5">
            <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 total Mayo Score ≤ 2 points, with no individual subscore &gt; 1 point.&#xD;
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.&#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 total Mayo 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 Mayo 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="116"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="98"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unadjusted remission rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="2.5"/>
                    <measurement group_id="O4" value="13.3"/>
                    <measurement group_id="O5" value="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted remission rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4"/>
                    <measurement group_id="O2" value="1.6"/>
                    <measurement group_id="O3" value="2.9"/>
                    <measurement group_id="O4" value="13.5"/>
                    <measurement group_id="O5" value="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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 total Mayo 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 and 210 mg groups. To account for multiplicity of statistical testing, primary and key secondary end points for the 2 highest doses of abrilumab (70 and 210 mg) were tested at the end of the 8-week induction period under a sequential framework at a 2-sided significance level of 0.10 using the Bonferroni-based chain procedure.</non_inferiority_desc>
            <p_value>0.021</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total Mayo Score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.35</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.41</ci_lower_limit>
            <ci_upper_limit>7.95</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 total Mayo 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>9.0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.6</ci_lower_limit>
            <ci_upper_limit>14.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo 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 and 210 mg groups. To account for multiplicity of statistical testing, primary and key secondary end points for the 2 highest doses of abrilumab (70 and 210 mg) were tested at the end of the 8-week induction period under a sequential framework at a 2-sided significance level of 0.10 using the Bonferroni-based chain procedure.</non_inferiority_desc>
            <p_value>0.030</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total Mayo Score and stratification factors</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.33</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.34</ci_lower_limit>
            <ci_upper_limit>8.26</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>O5</group_id>
            </group_id_list>
            <groups_desc>The difference in remission rates, estimated from a logistic regression model adjusted for baseline total Mayo 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>8.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8</ci_lower_limit>
            <ci_upper_limit>14.9</ci_upper_limit>
          </analysis>
          <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 from a logistic regression model adjusted for baseline total Mayo 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>Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.</non_inferiority_desc>
            <p_value>0.64</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total Mayo Score and stratification factors</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.64</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.13</ci_lower_limit>
            <ci_upper_limit>3.17</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 total Mayo 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>-1.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.2</ci_lower_limit>
            <ci_upper_limit>5.5</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 from a logistic regression model adjusted for baseline total Mayo 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>Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.</non_inferiority_desc>
            <p_value>0.49</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total Mayo Score and stratification factors</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.34</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.03</ci_lower_limit>
            <ci_upper_limit>4.33</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 total Mayo 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>-2.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.5</ci_lower_limit>
            <ci_upper_limit>5.4</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 by a decrease from baseline in the total Mayo Score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore ≥ 1 point or an absolute rectal bleeding subscore = 0 or 1.&#xD;
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment), each graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, ranging from 0 to 12 points. Higher scores represent more severe disease.&#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 total Mayo 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 Mayo 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 7 mg Q4W</title>
            <description>Participants randomized to receive 7 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="O3">
            <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 thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <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="O5">
            <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 by a decrease from baseline in the total Mayo Score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore ≥ 1 point or an absolute rectal bleeding subscore = 0 or 1.&#xD;
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment), each graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, ranging from 0 to 12 points. Higher scores represent more severe disease.&#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 total Mayo 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 Mayo 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="116"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="98"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unadjusted response rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9"/>
                    <measurement group_id="O2" value="14.3"/>
                    <measurement group_id="O3" value="50.0"/>
                    <measurement group_id="O4" value="49.0"/>
                    <measurement group_id="O5" value="46.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted response rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.0"/>
                    <measurement group_id="O2" value="12.3"/>
                    <measurement group_id="O3" value="47.2"/>
                    <measurement group_id="O4" value="49.4"/>
                    <measurement group_id="O5" value="47.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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 total Mayo 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>If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total Mayo Score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.78</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.71</ci_lower_limit>
            <ci_upper_limit>4.52</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 adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo 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>23.4</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.8</ci_lower_limit>
            <ci_upper_limit>33.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo 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>If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.</non_inferiority_desc>
            <p_value>0.003</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total Mayo Score and stratification factors</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.57</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.53</ci_lower_limit>
            <ci_upper_limit>4.31</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>O5</group_id>
            </group_id_list>
            <groups_desc>The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo 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>21.4</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.0</ci_lower_limit>
            <ci_upper_limit>31.8</ci_upper_limit>
          </analysis>
          <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 from a logistic regression model adjusted for baseline total Mayo 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>Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.</non_inferiority_desc>
            <p_value>0.024</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total Mayo Score and stratification factors</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.54</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.29</ci_lower_limit>
            <ci_upper_limit>5.02</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 adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo 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>21.2</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.9</ci_lower_limit>
            <ci_upper_limit>34.1</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 from a logistic regression model adjusted for baseline total Mayo 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>Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.</non_inferiority_desc>
            <p_value>0.18</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total Mayo Score and stratification factors</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.40</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.13</ci_lower_limit>
            <ci_upper_limit>1.22</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 adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo 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>-13.7</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.4</ci_lower_limit>
            <ci_upper_limit>2.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Mucosal Healing at Week 8</title>
        <description>Mucosal healing was defined using the rectosigmoidoscopy subscore of Mayo assessment as absolute subscore for rectosigmoidoscopy of 0 or 1.&#xD;
Flexible rectosigmoidoscopy was performed as part of the Mayo assessment, graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status.&#xD;
The healing rate (percentage of participants with mucosal healing) was calculated based on observed data (unadjusted healing 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 rectosigmoidoscopy score (adjusted healing 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 healing rates were calculated using non-responder imputation, where participants with missing rectosigmoidoscopy scores 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 7 mg Q4W</title>
            <description>Participants randomized to receive 7 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="O3">
            <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 thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <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="O5">
            <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 Mucosal Healing at Week 8</title>
          <description>Mucosal healing was defined using the rectosigmoidoscopy subscore of Mayo assessment as absolute subscore for rectosigmoidoscopy of 0 or 1.&#xD;
Flexible rectosigmoidoscopy was performed as part of the Mayo assessment, graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status.&#xD;
The healing rate (percentage of participants with mucosal healing) was calculated based on observed data (unadjusted healing 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 rectosigmoidoscopy score (adjusted healing rate).</description>
          <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted healing rates were calculated using non-responder imputation, where participants with missing rectosigmoidoscopy scores 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="116"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="98"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unadjusted healing rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6"/>
                    <measurement group_id="O2" value="14.3"/>
                    <measurement group_id="O3" value="15.0"/>
                    <measurement group_id="O4" value="32.7"/>
                    <measurement group_id="O5" value="29.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted healing rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8"/>
                    <measurement group_id="O2" value="12.2"/>
                    <measurement group_id="O3" value="13.9"/>
                    <measurement group_id="O4" value="32.2"/>
                    <measurement group_id="O5" value="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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 healing rates estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy 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>If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.</non_inferiority_desc>
            <p_value>0.011</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline rectosigmoidoscopy score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.34</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.35</ci_lower_limit>
            <ci_upper_limit>4.07</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher healing 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 adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy 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 Healing Rates</param_type>
            <param_value>15.3</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.8</ci_lower_limit>
            <ci_upper_limit>24.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy 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>If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.</non_inferiority_desc>
            <p_value>0.041</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline rectosigmoidoscopy score and stratification factors</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.10</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.15</ci_lower_limit>
            <ci_upper_limit>3.82</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy 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 Healing Rates</param_type>
            <param_value>13.0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.7</ci_lower_limit>
            <ci_upper_limit>22.1</ci_upper_limit>
          </analysis>
          <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 healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy 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>Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.</non_inferiority_desc>
            <p_value>0.68</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline rectosigmoidoscopy score and stratification factors</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.32</ci_lower_limit>
            <ci_upper_limit>1.97</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher healing 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 adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy 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 Healing Rates</param_type>
            <param_value>-3.0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.9</ci_lower_limit>
            <ci_upper_limit>9.4</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 healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy 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>Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.</non_inferiority_desc>
            <p_value>0.60</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline rectosigmoidoscopy score and stratification factors</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.69</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.21</ci_lower_limit>
            <ci_upper_limit>2.22</ci_upper_limit>
            <estimate_desc>An odds ratio &gt; 1.0 indicates a higher healing 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 adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy 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 Healing Rates</param_type>
            <param_value>-4.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.9</ci_lower_limit>
            <ci_upper_limit>11.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Remission at Week 8 and Week 24</title>
        <description>Remission was defined as a total Mayo Score ≤ 2 points, with no individual subscore &gt; 1 point. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24.&#xD;
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment), each graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher scores represent more severe disease status. The total Mayo Score is the sum of the four item scores, with a and ranges from 0 to 12 points. Higher scores represent more severe disease.&#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 total Mayo 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 non-adjusted and adjusted remission rates were calculated using non-responder imputation, where participants with missing Mayo Score at week 8 or week 16 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 7 mg Q4W</title>
            <description>Participants randomized to receive 7 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="O3">
            <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 thereafter until week 24 during the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <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="O5">
            <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 Week 8 and Week 24</title>
          <description>Remission was defined as a total Mayo Score ≤ 2 points, with no individual subscore &gt; 1 point. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24.&#xD;
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment), each graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher scores represent more severe disease status. The total Mayo Score is the sum of the four item scores, with a and ranges from 0 to 12 points. Higher scores represent more severe disease.&#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 total Mayo Score (adjusted remission rate).</description>
          <population>The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both non-adjusted and adjusted remission rates were calculated using non-responder imputation, where participants with missing Mayo Score at week 8 or week 16 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="116"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="98"/>
                <count group_id="O5" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unadjusted remission rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="2.5"/>
                    <measurement group_id="O4" value="8.2"/>
                    <measurement group_id="O5" value="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted remission rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3"/>
                    <measurement group_id="O2" value="1.6"/>
                    <measurement group_id="O3" value="2.8"/>
                    <measurement group_id="O4" value="9.1"/>
                    <measurement group_id="O5" value="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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 total Mayo 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>0.090</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total Mayo Score and stratification factors.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.94</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.03</ci_lower_limit>
            <ci_upper_limit>8.36</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 adjusted sustained remission rates, estimated from a logistic regression model adjusted for baseline total Mayo 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>5.8</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>10.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo 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>0.72</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total Mayo Score and stratification factors</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.32</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.38</ci_lower_limit>
            <ci_upper_limit>4.56</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>O5</group_id>
            </group_id_list>
            <groups_desc>The difference in adjusted sustained remission rates, estimated from a logistic regression model adjusted for baseline total Mayo 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>1.0</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>4.6</ci_upper_limit>
          </analysis>
          <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 from a logistic regression model adjusted for baseline total Mayo 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>Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.</non_inferiority_desc>
            <p_value>0.86</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total Mayo Score and stratification factors</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.83</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.16</ci_lower_limit>
            <ci_upper_limit>4.41</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>O3</group_id>
            </group_id_list>
            <groups_desc>The difference in adjusted sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo 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>-0.5</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>6.2</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 sustained remission rates from a logistic regression model adjusted for baseline total Mayo 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>Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.</non_inferiority_desc>
            <p_value>0.64</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted for baseline total Mayo Score and stratification factors</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.49</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>6.31</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 adjusted sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo 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>-1.7</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.2</ci_lower_limit>
            <ci_upper_limit>6.4</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 who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments 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 7 mg Q4W</title>
          <description>Participants received 7 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="E3">
          <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="E4">
          <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="E5">
          <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="E6">
          <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="E7">
          <title>OL Period: Abrilumab 7 mg Q4W/210 mg Q3M</title>
          <description>Participants who received 7 mg abrilumab Q4W in 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>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="E9">
          <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="E10">
          <title>OL 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="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="14" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="68"/>
              </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="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Haemolytic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Heart valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Gastrointestinal dysplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Megacolon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Sarcoidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </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="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Anal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Gastroenteritis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Perineal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post lumbar puncture syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Norovirus test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </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="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Ankylosing spondylitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Epstein-Barr virus associated lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pharyngeal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pemphigoid</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </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="47" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="55" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="35" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="55" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="19" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="53" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="26" subjects_at_risk="68"/>
              </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="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Phimosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="17" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="11" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="22" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="8" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Localised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood phosphorus decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </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="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Weight gain poor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </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="5" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="9" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="8" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Rheumatic disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </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="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="99"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="68"/>
              </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/NCT01694485
org study id: 20110166
secondary id: 2011-005251-13
nct id: NCT01694485
lead sponsor: 
has dmc: Yes
The primary objective of this study is to evaluate the effect of abrilumab on induction of
      remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as
      assessed by a total Mayo Score ≤ 2 points, with no individual subscore > 1 point.
The study consisted of a 24-week double-blind, placebo-controlled treatment period followed
      by an open-label period of approximately 108 weeks. Participants were eligible to enter the
      open-label period of the study early if they did not achieve a response at week 8 and had an
      inadequate response at week 12 or later or if they experienced disease worsening after
      achieving response and/or remission at week 8. Failure to achieve response at week 8 was
      defined as failure to achieve a decrease from baseline in total Mayo Score ≥ 3 points and ≥
      30% decrease from baseline. Inadequate response at week 12 or later was defined as failure to
      achieve a 2-point decrease and 25% improvement in partial Mayo Score compared with screening
      and minimum partial Mayo Score ≥ 5 points. Disease worsening was defined as an increase in
      partial Mayo Score ≥ 3 points from the week 8 value and minimum partial Mayo Score ≥ 5 points
      with recto-sigmoidoscopy sub-score ≥ 2.

      Participants were planned to be randomized in a 2:1:2:2:2 ratio to placebo or abrilumab at 7
      mg, 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 4:3:2. 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 total Mayo Score ≤ 2 points, with no individual subscore > 1 point.
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.
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 total Mayo Score (adjusted remission rate).
measure: Percentage of Participants With Response at Week 8
time frame: Baseline and week 8
description: Response was defined by a decrease from baseline in the total Mayo Score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore ≥ 1 point or an absolute rectal bleeding subscore = 0 or 1.
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment), each graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, ranging from 0 to 12 points. Higher scores represent more severe disease.
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 total Mayo Score (adjusted response rate).
measure: Percentage of Participants With Mucosal Healing at Week 8
time frame: Week 8
description: Mucosal healing was defined using the rectosigmoidoscopy subscore of Mayo assessment as absolute subscore for rectosigmoidoscopy of 0 or 1.
Flexible rectosigmoidoscopy was performed as part of the Mayo assessment, graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status.
The healing rate (percentage of participants with mucosal healing) was calculated based on observed data (unadjusted healing 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 rectosigmoidoscopy score (adjusted healing rate).
measure: Percentage of Participants With Sustained Remission at Week 8 and Week 24
time frame: Week 8 and week 24
description: Remission was defined as a total Mayo Score ≤ 2 points, with no individual subscore > 1 point. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24.
The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment), each graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher scores represent more severe disease status. The total Mayo Score is the sum of the four item scores, with a and ranges from 0 to 12 points. Higher scores represent more severe disease.
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 total Mayo Score (adjusted remission rate).
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 7 mg Q4W/Abrilumab 210 mg Q3M
arm group type: Experimental
description: Participants received 7 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 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 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: Biological
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 7 mg Q4W/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
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country: Australia
country: Austria
country: Belgium
country: Canada
country: Czechia
country: Denmark
country: Estonia
country: France
country: Germany
country: Greece
country: Hungary
country: Italy
country: Latvia
country: Netherlands
country: Norway
country: Poland
country: Russian Federation
country: Switzerland
country: United Kingdom
country: United States
country: Czech Republic
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 