<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/NCT01680159</url>
  </required_header>
  <id_info>
    <org_study_id>TA-650-24</org_study_id>
    <nct_id>NCT01680159</nct_id>
  </id_info>
  <brief_title>A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mitsubishi Tanabe Pharma Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mitsubishi Tanabe Pharma Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650&#xD;
      at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the&#xD;
      treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but&#xD;
      decreased thereafter.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Patients with plaque psoriasis or psoriatic arthritis:&#xD;
&#xD;
             1. Screening Period:&#xD;
&#xD;
                TA-650 at 5 mg per kg body weight is administered on the day of TA-650&#xD;
                administration at the start (week 0) and week 8 (if efficacy is not judged as&#xD;
                decreased or maintained at week 8 of the screening period) , respectively, by&#xD;
                intravenous infusion slowly over at least 2 hours.&#xD;
&#xD;
             2. Increased Dose Period:&#xD;
&#xD;
                If efficacy is judged as decreased in the screening period, TA-650 at 10 mg per kg&#xD;
                body weight is administered on the day of TA-650 administration at the start (week&#xD;
                0) and at every 8 weeks up to week 32 in the increased dose period , respectively,&#xD;
                as one dose by intravenous infusion slowly over at least 2 hours.&#xD;
&#xD;
        -  Patients with pustular psoriasis or psoriatic erythroderma:&#xD;
&#xD;
      TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the&#xD;
      start (week 0) and at every 8 weeks up to week 32, respectively, as one dose by intravenous&#xD;
      infusion slowly over at least 2 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score</measure>
    <time_frame>Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period</time_frame>
    <description>The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions.&#xD;
When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered.&#xD;
As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs).&#xD;
The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psoriasis Area and Severity Index (PASI) Score</measure>
    <time_frame>Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period</time_frame>
    <description>Score range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)</measure>
    <time_frame>Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period</time_frame>
    <description>The investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions.&#xD;
0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)</measure>
    <time_frame>Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period</time_frame>
    <description>From 0 (best) to 100 (worst)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Severity (Only for Patients With Pustular Psoriasis)</measure>
    <time_frame>Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period</time_frame>
    <description>From 0 (best) to 17 (worst)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Plaque Psoriasis</condition>
  <condition>Psoriatic Arthritis</condition>
  <condition>Pustular Psoriasis (Excluding a Localized)</condition>
  <condition>Psoriatic Erythroderma</condition>
  <arm_group>
    <arm_group_label>TA-650</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TA-650</intervention_name>
    <arm_group_label>TA-650</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have already been diagnosed as having plaque psoriasis, psoriatic&#xD;
             arthritis, pustular psoriasis (excluding a localized), or psoriatic erythroderma.&#xD;
&#xD;
          -  Patients in whom effect of the treatment was confirmed for a certain period after the&#xD;
             start of administration of Remicade® at 5 mg/kg at every 8 weeks but decreased&#xD;
             thereafter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have guttate psoriasis.&#xD;
&#xD;
          -  Patients who have drug-induced psoriasis&#xD;
&#xD;
          -  Patients who have previously used any other biological products than infliximab.&#xD;
&#xD;
          -  Patients who have a concomitant diagnosis, or a history within 6 months prior to&#xD;
             provisional enrollment, of serious infections that need hospitalization.&#xD;
&#xD;
          -  Patients who have a concomitant diagnosis, or a history within 6 months prior to&#xD;
             provisional enrollment, of opportunistic infections&#xD;
&#xD;
          -  Female patients who are pregnant, breast-feeding, or possibly pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hideshi Torii, MD</last_name>
    <role>Study Director</role>
    <affiliation>Social Insurance Central General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kazuoki Kondo, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mitsubihsi Tanabe Pharma Corporation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hidemi Nakagawa, MD</last_name>
    <role>Study Chair</role>
    <affiliation>The Jikei University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational site</name>
      <address>
        <city>Chubu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site</name>
      <address>
        <city>Chugoku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site</name>
      <address>
        <city>Kanto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site</name>
      <address>
        <city>Kinki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site</name>
      <address>
        <city>Kyushu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site</name>
      <address>
        <city>Tohoku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <results_first_submitted>November 9, 2016</results_first_submitted>
  <results_first_submitted_qc>January 23, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 13, 2017</results_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infliximab</keyword>
  <keyword>REMICADE</keyword>
  <keyword>TA-650</keyword>
  <keyword>psoriasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis, Psoriatic</mesh_term>
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Dermatitis, Exfoliative</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Patients of Pustular Psoriasis and Psoriatic Erythroderma could directly receive doses of TA-650 10mg per 1kg not to go though screening period.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>TA-650</title>
          <description>During the normal dose period, patients received doses of TA-650 5 mg per 1 kg body weight as a slow intravenous infusion over at least 2 hours on the treatment day at week 0, and at week 8 (if patients were not assessed as being either &quot;efficacy attenuated&quot; or &quot;efficacy maintained&quot; at week 8 of the normal dose period).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Screening Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Not meet criteria for dose-up period</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Increased Dose Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Plaque Psoriasis</title>
          <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
        </group>
        <group group_id="B2">
          <title>Psoriatic Arthritis</title>
          <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
        </group>
        <group group_id="B3">
          <title>Pustular Psoriasis</title>
          <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
        </group>
        <group group_id="B4">
          <title>Psoriatic Erythroderma</title>
          <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</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="31"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="7"/>
            <count group_id="B4" value="5"/>
            <count group_id="B5" value="51"/>
          </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="51.2" spread="13.9"/>
                    <measurement group_id="B2" value="50.1" spread="11.9"/>
                    <measurement group_id="B3" value="36.7" spread="9.7"/>
                    <measurement group_id="B4" value="55.8" spread="12.5"/>
                    <measurement group_id="B5" value="49.5" spread="13.7"/>
                  </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="25"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score</title>
        <description>The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions.&#xD;
When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered.&#xD;
As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs).&#xD;
The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point.</description>
        <time_frame>Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overall</title>
            <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
          </group>
          <group group_id="O2">
            <title>Plaque Psoriasis</title>
            <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
          </group>
          <group group_id="O3">
            <title>Psoriatic Arthritis</title>
            <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
          </group>
          <group group_id="O4">
            <title>Pustular Psoriasis</title>
            <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
          </group>
          <group group_id="O5">
            <title>Psoriatic Erythroderma</title>
            <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score</title>
          <description>The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions.&#xD;
When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered.&#xD;
As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs).&#xD;
The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0 (n=51,31,8,7,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=51,31,8,7,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.7"/>
                    <measurement group_id="O2" value="16.1"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (n=50,31,8,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.0"/>
                    <measurement group_id="O2" value="16.1"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="33.3"/>
                    <measurement group_id="O5" value="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=49,30,8,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.7"/>
                    <measurement group_id="O2" value="40.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="50.0"/>
                    <measurement group_id="O5" value="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 (n=48,29,8,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.3"/>
                    <measurement group_id="O2" value="34.5"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="50.0"/>
                    <measurement group_id="O5" value="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20 (n=46,28,7,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="53.6"/>
                    <measurement group_id="O3" value="14.3"/>
                    <measurement group_id="O4" value="50.0"/>
                    <measurement group_id="O5" value="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=45,27,7,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0"/>
                    <measurement group_id="O2" value="40.7"/>
                    <measurement group_id="O3" value="42.9"/>
                    <measurement group_id="O4" value="33.3"/>
                    <measurement group_id="O5" value="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28 (n=44,26,7,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.6"/>
                    <measurement group_id="O2" value="69.2"/>
                    <measurement group_id="O3" value="28.6"/>
                    <measurement group_id="O4" value="83.3"/>
                    <measurement group_id="O5" value="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32 (n=44,26,7,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.5"/>
                    <measurement group_id="O2" value="38.5"/>
                    <measurement group_id="O3" value="42.9"/>
                    <measurement group_id="O4" value="50.0"/>
                    <measurement group_id="O5" value="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=44,26,7,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.7"/>
                    <measurement group_id="O2" value="42.3"/>
                    <measurement group_id="O3" value="28.6"/>
                    <measurement group_id="O4" value="66.7"/>
                    <measurement group_id="O5" value="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40 (n=43,26,7,5,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.2"/>
                    <measurement group_id="O2" value="30.8"/>
                    <measurement group_id="O3" value="42.9"/>
                    <measurement group_id="O4" value="80.0"/>
                    <measurement group_id="O5" value="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Psoriasis Area and Severity Index (PASI) Score</title>
        <description>Score range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions.</description>
        <time_frame>Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overall</title>
            <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
          </group>
          <group group_id="O2">
            <title>Plaque Psoriasis</title>
            <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
          </group>
          <group group_id="O3">
            <title>Psoriatic Arthritis</title>
            <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
          </group>
          <group group_id="O4">
            <title>Pustular Psoriasis</title>
            <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
          </group>
          <group group_id="O5">
            <title>Psoriatic Erythroderma</title>
            <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Psoriasis Area and Severity Index (PASI) Score</title>
          <description>Score range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0 (n=51,31,8,7,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.70" lower_limit="3.0" upper_limit="44.0"/>
                    <measurement group_id="O2" value="12.80" lower_limit="4.6" upper_limit="44.0"/>
                    <measurement group_id="O3" value="13.95" lower_limit="3.0" upper_limit="29.2"/>
                    <measurement group_id="O4" value="14.70" lower_limit="3.1" upper_limit="37.2"/>
                    <measurement group_id="O5" value="22.20" lower_limit="14.7" upper_limit="35.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=51,31,8,7,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.60" lower_limit="0.6" upper_limit="30.7"/>
                    <measurement group_id="O2" value="6.20" lower_limit="1.0" upper_limit="29.4"/>
                    <measurement group_id="O3" value="8.20" lower_limit="0.6" upper_limit="28.0"/>
                    <measurement group_id="O4" value="9.90" lower_limit="3.0" upper_limit="19.3"/>
                    <measurement group_id="O5" value="9.20" lower_limit="4.2" upper_limit="30.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (n=50,31,8,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.25" lower_limit="0.8" upper_limit="46.0"/>
                    <measurement group_id="O2" value="7.50" lower_limit="1.0" upper_limit="46.0"/>
                    <measurement group_id="O3" value="8.20" lower_limit="0.8" upper_limit="27.6"/>
                    <measurement group_id="O4" value="4.20" lower_limit="1.2" upper_limit="34.8"/>
                    <measurement group_id="O5" value="14.00" lower_limit="3.5" upper_limit="34.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=49,30,8,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.40" lower_limit="0.7" upper_limit="39.3"/>
                    <measurement group_id="O2" value="4.40" lower_limit="0.7" upper_limit="39.3"/>
                    <measurement group_id="O3" value="6.60" lower_limit="0.8" upper_limit="24.1"/>
                    <measurement group_id="O4" value="3.70" lower_limit="1.2" upper_limit="20.9"/>
                    <measurement group_id="O5" value="3.40" lower_limit="1.6" upper_limit="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 (n=48,29,8,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.80" lower_limit="0.4" upper_limit="39.6"/>
                    <measurement group_id="O2" value="6.60" lower_limit="0.4" upper_limit="16.2"/>
                    <measurement group_id="O3" value="6.60" lower_limit="1.3" upper_limit="24.9"/>
                    <measurement group_id="O4" value="7.40" lower_limit="0.4" upper_limit="23.0"/>
                    <measurement group_id="O5" value="9.50" lower_limit="1.5" upper_limit="39.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20 (n=46,28,7,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.80" lower_limit="0.0" upper_limit="22.0"/>
                    <measurement group_id="O2" value="3.95" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O3" value="3.80" lower_limit="1.2" upper_limit="22.0"/>
                    <measurement group_id="O4" value="4.80" lower_limit="2.1" upper_limit="15.8"/>
                    <measurement group_id="O5" value="3.40" lower_limit="1.2" upper_limit="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=45,27,7,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.80" lower_limit="0.4" upper_limit="27.9"/>
                    <measurement group_id="O2" value="4.70" lower_limit="0.4" upper_limit="15.1"/>
                    <measurement group_id="O3" value="4.80" lower_limit="0.4" upper_limit="18.8"/>
                    <measurement group_id="O4" value="5.80" lower_limit="2.0" upper_limit="14.0"/>
                    <measurement group_id="O5" value="5.60" lower_limit="2.4" upper_limit="27.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28 (n=44,26,7,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.25" lower_limit="0.0" upper_limit="20.4"/>
                    <measurement group_id="O2" value="3.25" lower_limit="0.0" upper_limit="11.9"/>
                    <measurement group_id="O3" value="4.20" lower_limit="0.0" upper_limit="20.4"/>
                    <measurement group_id="O4" value="2.75" lower_limit="0.8" upper_limit="6.3"/>
                    <measurement group_id="O5" value="5.30" lower_limit="0.9" upper_limit="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32 (n=44,26,7,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.70" lower_limit="0.0" upper_limit="25.3"/>
                    <measurement group_id="O2" value="4.50" lower_limit="0.0" upper_limit="21.6"/>
                    <measurement group_id="O3" value="4.20" lower_limit="0.4" upper_limit="16.4"/>
                    <measurement group_id="O4" value="6.05" lower_limit="1.2" upper_limit="8.8"/>
                    <measurement group_id="O5" value="4.80" lower_limit="0.9" upper_limit="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=44,26,7,6,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.40" lower_limit="0.0" upper_limit="29.8"/>
                    <measurement group_id="O2" value="3.40" lower_limit="0.0" upper_limit="18.3"/>
                    <measurement group_id="O3" value="1.80" lower_limit="0.0" upper_limit="29.8"/>
                    <measurement group_id="O4" value="3.15" lower_limit="2.5" upper_limit="11.7"/>
                    <measurement group_id="O5" value="3.90" lower_limit="0.9" upper_limit="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40 (n=43,26,7,5,5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.70" lower_limit="0.0" upper_limit="29.3"/>
                    <measurement group_id="O2" value="4.70" lower_limit="0.0" upper_limit="27.6"/>
                    <measurement group_id="O3" value="2.40" lower_limit="0.8" upper_limit="29.3"/>
                    <measurement group_id="O4" value="2.70" lower_limit="2.1" upper_limit="6.2"/>
                    <measurement group_id="O5" value="3.30" lower_limit="2.7" upper_limit="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)</title>
        <description>The investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions.&#xD;
0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe</description>
        <time_frame>Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Plaque Psoriasis</title>
            <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)</title>
          <description>The investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions.&#xD;
0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0 (n=31)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=31)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (n=31)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 (n=29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20 (n=28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=27)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28 (n=26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32 (n=26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40 (n=26)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)</title>
        <description>From 0 (best) to 100 (worst)</description>
        <time_frame>Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Psoriatic Arthritis</title>
            <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)</title>
          <description>From 0 (best) to 100 (worst)</description>
          <units>mm</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.5" lower_limit="10" upper_limit="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0" lower_limit="5" upper_limit="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.5" lower_limit="4" upper_limit="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" lower_limit="4" upper_limit="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.0" lower_limit="5" upper_limit="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.0" lower_limit="4" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.0" lower_limit="4" upper_limit="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.0" lower_limit="3" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="6" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="2" upper_limit="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.0" lower_limit="2" upper_limit="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Severity (Only for Patients With Pustular Psoriasis)</title>
        <description>From 0 (best) to 17 (worst)</description>
        <time_frame>Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pustular Psoriasis</title>
            <description>From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Severity (Only for Patients With Pustular Psoriasis)</title>
          <description>From 0 (best) to 17 (worst)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="4" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="1" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (n=6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 (n=6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20 (n=6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28 (n=6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32 (n=6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40 (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>TA-650（Normal Dose Period）Overall</title>
          <description>Overall(Plaque Psoriasis・Psoriatic Arthritis)</description>
        </group>
        <group group_id="E2">
          <title>TA-650（Normal Dose Period）Plaque Psoriasis</title>
          <description>Plaque Psoriasis</description>
        </group>
        <group group_id="E3">
          <title>TA-650（Normal Dose Period）Psoriatic Arthritis</title>
          <description>Psoriatic Arthritis</description>
        </group>
        <group group_id="E4">
          <title>TA-650（Dose Escalation Period）Overall</title>
          <description>Overall(Plaque Psoriasis・Psoriatic Arthritis・Pustular Psoriasis・Psoriatic Erythroderma)</description>
        </group>
        <group group_id="E5">
          <title>TA-650（Dose Escalation Period）Plaque Psoriasis</title>
          <description>Plaque Psoriasis</description>
        </group>
        <group group_id="E6">
          <title>TA-650（Dose Escalation Period）Psoriatic Arthritis</title>
          <description>Psoriatic Arthritis</description>
        </group>
        <group group_id="E7">
          <title>TA-650（Dose Escalation Period）Pustular Psoriasis</title>
          <description>Pustular Psoriasis</description>
        </group>
        <group group_id="E8">
          <title>TA-650（Dose Escalation Period）Psoriatic Erythroderma</title>
          <description>Psoriatic Erythroderma</description>
        </group>
        <group group_id="E9">
          <title>TA-650（Entire Evaluation Period）Plaque Psoriasis</title>
          <description>Plaque Psoriasis</description>
        </group>
        <group group_id="E10">
          <title>TA-650（Entire Evaluation Period）Psoriatic Arthritis</title>
          <description>Psoriatic Arthritis</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Bacterial pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="47" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="30" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="34" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="9" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness unilateral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sudden hearing loss</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Iridocyclitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Keratitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Chapped lips</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Enteritis infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="8" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vaginitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vulvovaginitis trichomonal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Limb crushing injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nail avulsion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood pressure decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood urine present</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Double stranded DNA antibody positive</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="25" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="18" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="25" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Interleukin level increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </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="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Trigger finger</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Gastric adenoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Post herpetic neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depressive symptom</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertonic bladder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysfunctional uterine bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diffuse alopecia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="10"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trials, Information Desk</name_or_title>
      <organization>Mitsubishi Tanabe Pharma Corporation</organization>
      <email>cti-inq-ml@ml.mt-pharma.co.jp</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01680159
org study id: TA-650-24
nct id: NCT01680159
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650
      at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the
      treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but
      decreased thereafter.
-  Patients with plaque psoriasis or psoriatic arthritis:

             1. Screening Period:

                TA-650 at 5 mg per kg body weight is administered on the day of TA-650
                administration at the start (week 0) and week 8 (if efficacy is not judged as
                decreased or maintained at week 8 of the screening period) , respectively, by
                intravenous infusion slowly over at least 2 hours.

             2. Increased Dose Period:

                If efficacy is judged as decreased in the screening period, TA-650 at 10 mg per kg
                body weight is administered on the day of TA-650 administration at the start (week
                0) and at every 8 weeks up to week 32 in the increased dose period , respectively,
                as one dose by intravenous infusion slowly over at least 2 hours.

        -  Patients with pustular psoriasis or psoriatic erythroderma:

      TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the
      start (week 0) and at every 8 weeks up to week 32, respectively, as one dose by intravenous
      infusion slowly over at least 2 hours.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
description: The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions.
When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered.
As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs).
The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point.
measure: Psoriasis Area and Severity Index (PASI) Score
time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
description: Score range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions.
measure: Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
description: The investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions.
0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe
measure: Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
description: From 0 (best) to 100 (worst)
measure: Assessment of Severity (Only for Patients With Pustular Psoriasis)
time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
description: From 0 (best) to 17 (worst)
arm group label: TA-650
arm group type: Experimental
intervention type: Drug
intervention name: TA-650
arm group label: TA-650
criteria: 
gender: All
minimum age: 16 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hideshi Torii, MD
role: Study Director
affiliation: Social Insurance Central General Hospital
last name: Kazuoki Kondo, MD
role: Study Director
affiliation: Mitsubihsi Tanabe Pharma Corporation
last name: Hidemi Nakagawa, MD
role: Study Chair
affiliation: The Jikei University School of Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Arthritis, Psoriatic
mesh term: Psoriasis
mesh term: Dermatitis, Exfoliative
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 