<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/NCT01708603</url>
  </required_header>
  <id_info>
    <org_study_id>20120103</org_study_id>
    <nct_id>NCT01708603</nct_id>
  </id_info>
  <brief_title>P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis</brief_title>
  <acronym>AMAGINE-2</acronym>
  <official_title>A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bausch Health Americas, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bausch Health Americas, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and efficacy of brodalumab at two different&#xD;
      doses&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      .The purpose of this study is to assess the safety and efficacy of brodalumab at two&#xD;
      different doses compared with placebo in participants with moderate to severe plaque&#xD;
      psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at&#xD;
      two different doses compared with ustekinumab in participants with moderate to severe plaque&#xD;
      psoriasis. A third purpose of this study is to assess the safety and efficacy of 4&#xD;
      maintenance regimens of brodalumab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12</measure>
    <time_frame>12 weeks</time_frame>
    <description>to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12</measure>
    <time_frame>12 Weeks</time_frame>
    <description>to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1831</enrollment>
  <condition>Moderate to Severe Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>210 mg brodalumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>140 mg brodalumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ustekinumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administered by subcutaneous (SC) injection per the labeled dosing regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>210 mg brodalumab</intervention_name>
    <description>210 mg brodalumab administered SC</description>
    <arm_group_label>210 mg brodalumab</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>140 mg brodalumab</intervention_name>
    <description>140 mg brodalumab administered SC</description>
    <arm_group_label>140 mg brodalumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ustekinumab</intervention_name>
    <description>45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.</description>
    <arm_group_label>ustekinumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Placebo administered SC</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has had stable moderate to severe plaque psoriasis for at least 6 months&#xD;
&#xD;
          -  Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at&#xD;
             screening and at baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,&#xD;
             medication-induced psoriasis, or other skin conditions at (eg, eczema) that would&#xD;
             interfere with study evaluations&#xD;
&#xD;
          -  Subject has known history of Crohn's disease&#xD;
&#xD;
          -  Subject has any other significant concurrent medical condition or laboratory&#xD;
             abnormalities, as defined in the study protocol&#xD;
&#xD;
          -  Subject has not stopped using certain psoriasis therapies as defined in the study&#xD;
             protocol&#xD;
&#xD;
          -  Subject has previously used ustekinumab or any anti-IL-17 biologic therapy&#xD;
&#xD;
          -  Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in&#xD;
             the study&#xD;
&#xD;
          -  Female subject is unwilling to use highly effective methods of birth control unless 2&#xD;
             years post-menopausal or surgically sterile&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 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>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <zip>71913</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vista</city>
        <state>California</state>
        <zip>92083</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</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>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</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>Newnan</city>
        <state>Georgia</state>
        <zip>30263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Snellville</city>
        <state>Georgia</state>
        <zip>30078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60654</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Skokie</city>
        <state>Illinois</state>
        <zip>60077</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plainfield</city>
        <state>Indiana</state>
        <zip>46168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Silver Spring</city>
        <state>Maryland</state>
        <zip>20902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>North Andover</city>
        <state>Massachusetts</state>
        <zip>01845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11209</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>Rochester</city>
        <state>New York</state>
        <zip>14625</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>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gahanna</city>
        <state>Ohio</state>
        <zip>43230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>South Euclid</city>
        <state>Ohio</state>
        <zip>44118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Alcorcon</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Hungary</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Spain</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>January 2020</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <results_first_submitted>October 31, 2016</results_first_submitted>
  <results_first_submitted_qc>January 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 6, 2020</results_first_posted>
  <disposition_first_submitted>April 20, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>April 20, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">May 7, 2015</disposition_first_posted>
  <last_update_submitted>January 3, 2020</last_update_submitted>
  <last_update_submitted_qc>January 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>psoriasis, brodalumab, AMG 827</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ustekinumab</mesh_term>
    <mesh_term>Brodalumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>210 mg Brodalumab</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC</description>
        </group>
        <group group_id="P2">
          <title>140 mg Brodalumab</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
140 mg brodalumab: 140 mg brodalumab administered SC</description>
        </group>
        <group group_id="P3">
          <title>Ustekinumab</title>
          <description>Administered by subcutaneous (SC) injection per the labeled dosing regimen.&#xD;
ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC&#xD;
placebo: Placebo administered SC</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="612"/>
                <participants group_id="P2" count="610"/>
                <participants group_id="P3" count="300"/>
                <participants group_id="P4" count="309"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="597"/>
                <participants group_id="P2" count="588"/>
                <participants group_id="P3" count="291"/>
                <participants group_id="P4" count="300"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>210 mg Brodalumab</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC</description>
        </group>
        <group group_id="B2">
          <title>140 mg Brodalumab</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
140 mg brodalumab: 140 mg brodalumab administered SC</description>
        </group>
        <group group_id="B3">
          <title>Ustekinumab</title>
          <description>Administered by subcutaneous (SC) injection per the labeled dosing regimen.&#xD;
ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC&#xD;
placebo: Placebo administered SC</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="612"/>
            <count group_id="B2" value="610"/>
            <count group_id="B3" value="300"/>
            <count group_id="B4" value="309"/>
            <count group_id="B5" value="1831"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.5" spread="12.7"/>
                    <measurement group_id="B2" value="44.8" spread="12.8"/>
                    <measurement group_id="B3" value="45.4" spread="13.0"/>
                    <measurement group_id="B4" value="43.7" spread="12.9"/>
                    <measurement group_id="B5" value="44.6" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="191"/>
                    <measurement group_id="B2" value="197"/>
                    <measurement group_id="B3" value="95"/>
                    <measurement group_id="B4" value="90"/>
                    <measurement group_id="B5" value="573"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="421"/>
                    <measurement group_id="B2" value="413"/>
                    <measurement group_id="B3" value="205"/>
                    <measurement group_id="B4" value="219"/>
                    <measurement group_id="B5" value="1258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="551"/>
                    <measurement group_id="B2" value="557"/>
                    <measurement group_id="B3" value="271"/>
                    <measurement group_id="B4" value="273"/>
                    <measurement group_id="B5" value="1652"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="33"/>
                    <measurement group_id="B5" value="195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="286"/>
                    <measurement group_id="B2" value="281"/>
                    <measurement group_id="B3" value="140"/>
                    <measurement group_id="B4" value="144"/>
                    <measurement group_id="B5" value="851"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="132"/>
                    <measurement group_id="B3" value="65"/>
                    <measurement group_id="B4" value="64"/>
                    <measurement group_id="B5" value="391"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Portugal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12</title>
        <description>Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>210 mg Brodalumab</title>
            <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC</description>
          </group>
          <group group_id="O2">
            <title>140 mg Brodalumab</title>
            <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
140 mg brodalumab: 140 mg brodalumab administered SC</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC&#xD;
placebo: Placebo administered SC</description>
          </group>
          <group group_id="O4">
            <title>Ustekinumab</title>
            <description>Administered by subcutaneous (SC) injection until week 12. Participants using Ustekinumab were not rerandomized at week 12, and continued to receive ustekinumab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12</title>
          <description>Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="612"/>
                <count group_id="O2" value="610"/>
                <count group_id="O3" value="309"/>
                <count group_id="O4" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="481"/>
                    <measurement group_id="O2" value="354"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12</title>
        <description>to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>210 mg Brodalumab</title>
            <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC</description>
          </group>
          <group group_id="O2">
            <title>140 mg Brodalumab</title>
            <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
140 mg brodalumab: 140 mg brodalumab administered SC</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Brodalumab Placebo</description>
          </group>
          <group group_id="O4">
            <title>Ustekinumab</title>
            <description>Administered by subcutaneous (SC) injection until week 12. Participants using Ustekinumab were not rerandomized at week 12, and continued to receive ustekinumab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12</title>
          <description>to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="612"/>
                <count group_id="O2" value="610"/>
                <count group_id="O3" value="309"/>
                <count group_id="O4" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="528"/>
                    <measurement group_id="O2" value="406"/>
                    <measurement group_id="O3" value="25"/>
                    <measurement group_id="O4" value="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12</title>
        <description>to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.</description>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Brodalumab 210mg</title>
            <description>Brodalumab 210mg Q2W</description>
          </group>
          <group group_id="O2">
            <title>Brodalumab 140mg</title>
            <description>Brodalumab 140mg Q2W</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Brodalumab placebo</description>
          </group>
          <group group_id="O4">
            <title>Ustekinumab</title>
            <description>Ustekinumab administered in a dose of 45mg in a prefilled syringe of 0.5mL</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12</title>
          <description>to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="612"/>
                <count group_id="O2" value="610"/>
                <count group_id="O3" value="309"/>
                <count group_id="O4" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="272"/>
                    <measurement group_id="O2" value="157"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>210 mg Brodalumab</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC</description>
        </group>
        <group group_id="E2">
          <title>140 mg Brodalumab</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.&#xD;
140 mg brodalumab: 140 mg brodalumab administered SC</description>
        </group>
        <group group_id="E3">
          <title>Ustekinumab</title>
          <description>Administered by subcutaneous (SC) injection per the labeled dosing regimen.&#xD;
ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.&#xD;
210 mg brodalumab: 210 mg brodalumab administered SC&#xD;
placebo: Placebo administered SC</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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="6" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Blood Glucose Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Angina Unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Anteriosclerosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes Mellitus Inadequate Control</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Dysponea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Noncardiac Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Alcohol Abuse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Chondromalacia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Chondropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Drug Detoxification</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Fibromyalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Escherichia Urinary tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hip Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Ligament Rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Carbon Monoxide Poisining</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Cerbebral Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Joint Capsule Rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Ligament Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Prostate Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Acute Coronary Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="354" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="365" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="177" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="165" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Peripheral Swelling</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Odema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Non-cardiac Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Upper respiratory Tract infection</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="23" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Urinary tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Viral Upper respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Oral Herpes</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Conjuncitvitus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Gastroenteritis Viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Tooth Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Otitis Media</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Muscle Strain</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Joint Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="309"/>
              </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="28" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Psoriatic Arthropathy</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Muskuloskelital Pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Muscle Spasms</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Joint Swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Groin Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Migrane</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Pruritus Generalized</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Dry Skin</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Seborrhoeic Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </event>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="610"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="309"/>
              </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 only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Bausch Health</organization>
      <phone>510-259-5284</phone>
    </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/NCT01708603
org study id: 20120103
nct id: NCT01708603
lead sponsor: 
has dmc: Yes
The purpose of this study is to assess the safety and efficacy of brodalumab at two different
      doses
.The purpose of this study is to assess the safety and efficacy of brodalumab at two
      different doses compared with placebo in participants with moderate to severe plaque
      psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at
      two different doses compared with ustekinumab in participants with moderate to severe plaque
      psoriasis. A third purpose of this study is to assess the safety and efficacy of 4
      maintenance regimens of brodalumab.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
time frame: 12 weeks
description: Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).
measure: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
time frame: 12 weeks
description: to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.
measure: Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12
time frame: 12 Weeks
description: to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.
arm group label: 210 mg brodalumab
arm group type: Experimental
description: Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
arm group label: 140 mg brodalumab
arm group type: Experimental
description: Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
arm group label: ustekinumab
arm group type: Active Comparator
description: Administered by subcutaneous (SC) injection per the labeled dosing regimen.
arm group label: Placebo
arm group type: Placebo Comparator
description: Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
intervention type: Drug
intervention name: 210 mg brodalumab
description: 210 mg brodalumab administered SC
arm group label: 210 mg brodalumab
arm group label: Placebo
intervention type: Drug
intervention name: 140 mg brodalumab
description: 140 mg brodalumab administered SC
arm group label: 140 mg brodalumab
intervention type: Drug
intervention name: ustekinumab
description: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
arm group label: ustekinumab
intervention type: Drug
intervention name: placebo
description: Placebo administered SC
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: Australia
country: Austria
country: Canada
country: Czechia
country: France
country: Hungary
country: Netherlands
country: Poland
country: Portugal
country: Spain
country: United States
country: Czech Republic
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Ustekinumab
mesh term: Brodalumab
mesh term: Antibodies, Monoclonal
sharing ipd: Yes
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 