<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/NCT01723072</url>
  </required_header>
  <id_info>
    <org_study_id>CIGE025EDE16</org_study_id>
    <nct_id>NCT01723072</nct_id>
  </id_info>
  <brief_title>Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy</brief_title>
  <acronym>X-ACT</acronym>
  <official_title>A Randomized, Double-blind, Placebo-controlled, 28-week Treatment With a 8 Week Follow-up to Investigate the Impact of Omalizumab on Quality of Life Measures and the Incidence and Severity of Angioedema Despite H1-antihistamine Therapy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the impact of omalizumab on the quality of life improvement when added&#xD;
      to the standard therapy in refractory patients suffering from chronic spontaneous urticaria&#xD;
      and angioedema.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be conducted using a double-blind, placebo-controlled, randomized,&#xD;
      multicenter design to investigate the impact of omalizumab on Quality of Life (QoL) in&#xD;
      Chronic Spontaneous Urticaria (CSU) and will assess its effectiveness in reducing and/or&#xD;
      inhibiting the occurrence, time-course and severity of angioedema episodes.&#xD;
&#xD;
      Omalizumab is administered subcutaneously every 4 weeks as an add-on therapy to the current&#xD;
      approved treatment of adult CSU patients. The treatment period is 28 weeks which is followed&#xD;
      by an 8-week follow-up. The study aims to enroll approximately 70 patients.&#xD;
&#xD;
      The study is divided into a 2-week screening period, a 28-week double-blind treatment phase&#xD;
      with omalizumab or placebo-omalizumab, and an 8-week follow-up phase.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2013</start_date>
  <completion_date type="Actual">May 9, 2014</completion_date>
  <primary_completion_date type="Actual">May 9, 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS)</measure>
    <time_frame>Baseline, 4, 12, 20, 28 and 36 weeks</time_frame>
    <description>The CU-Q2oL is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It consists of 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Participants are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1= not at all to 5= very much). An overall score is calculated and normalized to a scale of 1 to 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Angioedema Burdened Days by Study Phase (Observed Cases With Imputation)</measure>
    <time_frame>Baseline, week 28; and the follow-up period (weeks 29-36)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes</measure>
    <time_frame>Baseline to week 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation)</measure>
    <time_frame>Baseline to week 28; and follow-up period (to week 36)</time_frame>
    <description>A cumulative activity score, evaluated in the screening period and throughout the study. The records each evening on a daily basis symptoms of itch and hives into a patient diary. min. score = 0 ; max. score= 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1)</measure>
    <time_frame>week -2 to -1</time_frame>
    <description>data points per group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28)</measure>
    <time_frame>weeks 25 to 28</time_frame>
    <description>data points per group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36)</measure>
    <time_frame>weeks 33 to 36</time_frame>
    <description>data points per group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1)</measure>
    <time_frame>weeks -2 to -1</time_frame>
    <description>data points per group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28)</measure>
    <time_frame>weeks 25 to 28</time_frame>
    <description>data points per group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36)</measure>
    <time_frame>weeks 33 to 36</time_frame>
    <description>data points per group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)</measure>
    <time_frame>baseline to week 28; and then follow-up to week 36</time_frame>
    <description>The AE-Q2oL is a questionnaire for patients suffering from angioedema. It consists of 29 questions relevant to angioedema and its specific impact on quality of life. Patients are asked to respond how much they are troubled be each problem on a 5-point Likert scale (1= does not apply to 5= very much). An overall score is calculated and a higher score indicates lower quality of life. A negative change score (week 28 score minus baseline score) indicates improvement.&#xD;
Each AE-QoL question has 5 answer options (scored 1-5), with lower and higher scores indicting less and more adverse impact, respectively. The total score is calculated, which is then transformed into a linear scale that ranges from 0 to 100, with a score of 100 indicating the worst possible impairment of HRQoL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue Medication During the Treatment Period</measure>
    <time_frame>baseline to 28 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of Rescue Medication During the Treatment Period</measure>
    <time_frame>baseline to 28 weeks</time_frame>
    <description>data points per group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of Rescue Medication During the Follow-up Period</measure>
    <time_frame>weeks 33 to 36</time_frame>
    <description>data points per group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)</measure>
    <time_frame>baseline to week 28; and then follow-up to week 36</time_frame>
    <description>The UAS7 is the sum of urticaria activity scores over a seven day period. The possible range of the weekly UAS7 score is 0-42. 0 means complete response and a better outcome and 42 means no response and a worse outcome.&#xD;
Complete UAS7 response is defined as UAS7=0. The UAS7 is the sum of the Hive Severity Score over seven days (HSS7) and the Itch Severity Score over seven days (ISS7) . The Hive Severity Score has a scale of 0 (none) to 3 (intense/severe). Complete hives response is defined as HSS7=0. The Itch Severity Score has a scale of 0 (None) to 3 (Severe (difficult to tolerate)). Complete itch response is defined as ISS7=0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)</measure>
    <time_frame>baseline to week 28; and follow-up to week 36</time_frame>
    <description>change in Dermatology Quality of Life Index scores&#xD;
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). &quot;Not relevant&quot; is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Chronic Spontaneous Urticaria</condition>
  <condition>Angioedema</condition>
  <arm_group>
    <arm_group_label>1 Omalizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>omalizumab once a month via subcutaneous injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo of omalizumab once a month via subcutaneous injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Omalizumab</intervention_name>
    <description>Humanized monoclonal antibody against human IgE</description>
    <arm_group_label>1 Omalizumab</arm_group_label>
    <other_name>IGE025</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo to omalizumab</description>
    <arm_group_label>2 Placebo</arm_group_label>
    <other_name>Placebo for Omalizumab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1-antihistamine&#xD;
             treatment&#xD;
&#xD;
          -  Presence of itch an hives for more than 6 weeks&#xD;
&#xD;
          -  UAS7 score of more than 14 (range 0-42)&#xD;
&#xD;
          -  Patient has history of insufficient response to 4x of the approved dose of&#xD;
             H1-antihistamines&#xD;
&#xD;
          -  CSU diagnosis for more than 6 months&#xD;
&#xD;
          -  Angioedema at least 4x in the last 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with non urticaria associated angioedema&#xD;
&#xD;
          -  History of hypersensitivity to omalizumab or the rescue medication or to drugs of&#xD;
             similar chemical structure&#xD;
&#xD;
          -  Evidence of parasitic infection&#xD;
&#xD;
          -  Previous treatment with omalizumab within the last 6 months prior to screening&#xD;
&#xD;
          -  History of anaphylactic shock&#xD;
&#xD;
          -  Woman who are pregnant or breast feeding&#xD;
&#xD;
          -  Other protocol-defined inclusion/exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Wuerttemberg</state>
        <zip>68305</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Regensburg</city>
        <state>Bavaria</state>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Koeln</city>
        <state>Nordrhein-Westfalen</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Augsburg</city>
        <zip>86179</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bonn</city>
        <zip>53105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Darmstadt</city>
        <zip>64283</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Duesseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Gera</city>
        <zip>07548</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Halle</city>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Homburg</city>
        <zip>66421</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Muenchen</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Muenchen</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Oldenburg</city>
        <zip>26133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Selters</city>
        <zip>56242</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Wiesbaden</city>
        <zip>65199</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <results_first_submitted>May 7, 2015</results_first_submitted>
  <results_first_submitted_qc>August 21, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 9, 2020</results_first_posted>
  <last_update_submitted>August 21, 2020</last_update_submitted>
  <last_update_submitted_qc>August 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic spontanous urticaria, refractory CSU, Angioedema</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angioedema</mesh_term>
    <mesh_term>Urticaria</mesh_term>
    <mesh_term>Chronic Urticaria</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Omalizumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Omalizumab</title>
          <description>Omalizumab once a month via subcutaneous injection.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo of omalizumab once a month via subcutaneous injection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44">28-week treatment period and 8-week follow-up period</participants>
                <participants group_id="P2" count="47">28-week treatment period and 8-week follow-up period</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discon for rescue medication after wk 24</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Omalizumab</title>
          <description>Omalizumab once a month via subcutaneous injection.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo of omalizumab once a month via subcutaneous injection</description>
        </group>
        <group group_id="B3">
          <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="44"/>
            <count group_id="B2" value="47"/>
            <count group_id="B3" value="91"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.9" spread="13.7"/>
                    <measurement group_id="B2" value="41.1" spread="10.6"/>
                    <measurement group_id="B3" value="42.9" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </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="30"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <description>Body Mass Index</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.3" spread="6.3"/>
                    <measurement group_id="B2" value="29.0" spread="5.9"/>
                    <measurement group_id="B3" value="28.2" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI group</title>
          <description>Body Mass Index group</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;18.5</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>18.5-25</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;25</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Never smoked</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Current smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ex-smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease history and baseline characteristics of angioedema (FAS)</title>
          <description>Frequency of prior angioedema episodes</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Daily</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Weekly</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;6 episodes per year</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt;6 episodes a year</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>[Disease history and baseline characteristics of angioedema (FAS)]</title>
          <description>Duration of symptoms of angioedema (usually)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;24 hours</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;24 hours</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease history and baseline characteristics of angioedema (FAS)</title>
          <description>Location of prior angioedema (any)</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Eyes/lids/periorbital</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lips/perioral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mouth/laryngeal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trunk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arms/legs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease history and baseline charactaristics</title>
          <description>Duration of disease before baseline</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.4" spread="9.3"/>
                    <measurement group_id="B2" value="7.4" spread="8.8"/>
                    <measurement group_id="B3" value="7.9" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease history and baseline charactaristics</title>
          <description>Duration of disease group - n</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;2 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2-10 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;10 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease history and baseline charactaristics</title>
          <description>Previous systemic corticosteroid use - n</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease history and baseline charactaristics</title>
          <description>Previous number of nsH1-n antihistamines - n</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=2 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3-5 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;5 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS)</title>
        <description>The CU-Q2oL is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It consists of 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Participants are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1= not at all to 5= very much). An overall score is calculated and normalized to a scale of 1 to 100.</description>
        <time_frame>Baseline, 4, 12, 20, 28 and 36 weeks</time_frame>
        <population>full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS)</title>
          <description>The CU-Q2oL is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It consists of 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Participants are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1= not at all to 5= very much). An overall score is calculated and normalized to a scale of 1 to 100.</description>
          <population>full analysis set</population>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>V3 (week 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.5" spread="21.3"/>
                    <measurement group_id="O2" value="-6.4" spread="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>V5 (week 12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.1" spread="21.8"/>
                    <measurement group_id="O2" value="-12.1" spread="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>V7 (week 20)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.4" spread="23.7"/>
                    <measurement group_id="O2" value="-16.2" spread="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>V9 (week 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.1" spread="24.2"/>
                    <measurement group_id="O2" value="-13.9" spread="17.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up (week 36)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.9" spread="23.0"/>
                    <measurement group_id="O2" value="-14.7" spread="19.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Angioedema Burdened Days by Study Phase (Observed Cases With Imputation)</title>
        <time_frame>Baseline, week 28; and the follow-up period (weeks 29-36)</time_frame>
        <population>full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Angioedema Burdened Days by Study Phase (Observed Cases With Imputation)</title>
          <population>full analysis set</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screening (Week -2 to -1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="3.9"/>
                    <measurement group_id="O2" value="6.8" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment (Week 1 to 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6" spread="19.5"/>
                    <measurement group_id="O2" value="49.5" spread="50.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up (Week 29 to 36)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="9.1"/>
                    <measurement group_id="O2" value="12.8" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes</title>
        <time_frame>Baseline to week 28</time_frame>
        <population>full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes</title>
          <population>full analysis set</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1st to 2nd episode</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" spread="41.63"/>
                    <measurement group_id="O2" value="7.8" spread="14.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2nd to 3rd episode</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" spread="19.52"/>
                    <measurement group_id="O2" value="7.2" spread="10.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3rd to 4th episode</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.4" spread="50.73"/>
                    <measurement group_id="O2" value="8.3" spread="13.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4th to 5th episode</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" spread="23.87"/>
                    <measurement group_id="O2" value="8.6" spread="20.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5th to 6th episode</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.2" spread="20.54"/>
                    <measurement group_id="O2" value="13.6" spread="30.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6th to 7th episode</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" spread="22.11"/>
                    <measurement group_id="O2" value="7.5" spread="11.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7th to 8th episode</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" spread="29.41"/>
                    <measurement group_id="O2" value="9.1" spread="17.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8th to 9th episode</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" spread="15.05"/>
                    <measurement group_id="O2" value="8.0" spread="12.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9th to 10th episode</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" spread="20.16"/>
                    <measurement group_id="O2" value="8.7" spread="12.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10th to 11th episode</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" spread="13.02"/>
                    <measurement group_id="O2" value="8.5" spread="10.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>11th to 12th episode</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" spread="9.42"/>
                    <measurement group_id="O2" value="9.4" spread="13.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12th to 13th episode</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="4.47"/>
                    <measurement group_id="O2" value="4.3" spread="4.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>13th to 14th episode</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="3.02"/>
                    <measurement group_id="O2" value="7.3" spread="4.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14th to 15th episode</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" spread="9.96"/>
                    <measurement group_id="O2" value="10.1" spread="11.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation)</title>
        <description>A cumulative activity score, evaluated in the screening period and throughout the study. The records each evening on a daily basis symptoms of itch and hives into a patient diary. min. score = 0 ; max. score= 100</description>
        <time_frame>Baseline to week 28; and follow-up period (to week 36)</time_frame>
        <population>full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation)</title>
          <description>A cumulative activity score, evaluated in the screening period and throughout the study. The records each evening on a daily basis symptoms of itch and hives into a patient diary. min. score = 0 ; max. score= 100</description>
          <population>full analysis set</population>
          <units>AAS (Angioedema Activity Score)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diary week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.7" spread="20.0"/>
                    <measurement group_id="O2" value="-5.0" spread="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diary week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.0" spread="22.4"/>
                    <measurement group_id="O2" value="-9.0" spread="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diary week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.3" spread="21.6"/>
                    <measurement group_id="O2" value="-16.9" spread="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diary week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.6" spread="21.5"/>
                    <measurement group_id="O2" value="-10.8" spread="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diary week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.6" spread="18.4"/>
                    <measurement group_id="O2" value="-15.3" spread="20.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1)</title>
        <description>data points per group</description>
        <time_frame>week -2 to -1</time_frame>
        <population>full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1)</title>
          <description>data points per group</description>
          <population>full analysis set</population>
          <units>Number of episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Acute swelling episode, Diameter &lt;10cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                    <measurement group_id="O2" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute swelling episode, Diameter 10-20cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute swelling episode, Diameter &gt;20cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28)</title>
        <description>data points per group</description>
        <time_frame>weeks 25 to 28</time_frame>
        <population>actual patient numbers</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28)</title>
          <description>data points per group</description>
          <population>actual patient numbers</population>
          <units>Number of episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Acute swelling episode, Diameter &lt;10cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute swelling episode, Diameter 10-20cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute swelling episode, Diameter 20cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36)</title>
        <description>data points per group</description>
        <time_frame>weeks 33 to 36</time_frame>
        <population>full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36)</title>
          <description>data points per group</description>
          <population>full analysis set</population>
          <units>Number of episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Acute swelling episode, Diameter &lt;10cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute swelling episode, Diameter 10-20cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute swelling episode, Diameter &gt;20cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1)</title>
        <description>data points per group</description>
        <time_frame>weeks -2 to -1</time_frame>
        <population>full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1)</title>
          <description>data points per group</description>
          <population>full analysis set</population>
          <units>number of episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Shortness of breath: No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="203"/>
                    <measurement group_id="O2" value="264"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shortness of breath: Slightly</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shortness of breath: Moderately</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shortness of breath: Severely</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28)</title>
        <description>data points per group</description>
        <time_frame>weeks 25 to 28</time_frame>
        <population>full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28)</title>
          <description>data points per group</description>
          <population>full analysis set</population>
          <units>Number of episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Shortness of breath: No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shortness of breath: Slightly</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shortness of breath: Moderately</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shortness of breath: Severely</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36)</title>
        <description>data points per group</description>
        <time_frame>weeks 33 to 36</time_frame>
        <population>full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36)</title>
          <description>data points per group</description>
          <population>full analysis set</population>
          <units>Number of episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="145"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Shortness of breath: No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shortness of breath: Slightly</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shortness of breath: Moderately</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shortness of breath: Severely</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)</title>
        <description>The AE-Q2oL is a questionnaire for patients suffering from angioedema. It consists of 29 questions relevant to angioedema and its specific impact on quality of life. Patients are asked to respond how much they are troubled be each problem on a 5-point Likert scale (1= does not apply to 5= very much). An overall score is calculated and a higher score indicates lower quality of life. A negative change score (week 28 score minus baseline score) indicates improvement.&#xD;
Each AE-QoL question has 5 answer options (scored 1-5), with lower and higher scores indicting less and more adverse impact, respectively. The total score is calculated, which is then transformed into a linear scale that ranges from 0 to 100, with a score of 100 indicating the worst possible impairment of HRQoL</description>
        <time_frame>baseline to week 28; and then follow-up to week 36</time_frame>
        <population>full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)</title>
          <description>The AE-Q2oL is a questionnaire for patients suffering from angioedema. It consists of 29 questions relevant to angioedema and its specific impact on quality of life. Patients are asked to respond how much they are troubled be each problem on a 5-point Likert scale (1= does not apply to 5= very much). An overall score is calculated and a higher score indicates lower quality of life. A negative change score (week 28 score minus baseline score) indicates improvement.&#xD;
Each AE-QoL question has 5 answer options (scored 1-5), with lower and higher scores indicting less and more adverse impact, respectively. The total score is calculated, which is then transformed into a linear scale that ranges from 0 to 100, with a score of 100 indicating the worst possible impairment of HRQoL</description>
          <population>full analysis set</population>
          <units>AE-QoL Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 4 (n=38,36)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.5" spread="20.4"/>
                    <measurement group_id="O2" value="-10.3" spread="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 12 (n= 35, 29)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.4" spread="23.8"/>
                    <measurement group_id="O2" value="-20.4" spread="27.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 20 (n=34,27)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.1" spread="26.5"/>
                    <measurement group_id="O2" value="-28.8" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 28 (n=34, 25)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-41.4" spread="25.7"/>
                    <measurement group_id="O2" value="-24.2" spread="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>follow-up, week 36 (n=33,23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.2" spread="26.4"/>
                    <measurement group_id="O2" value="-24.6" spread="23.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rescue Medication During the Treatment Period</title>
        <time_frame>baseline to 28 weeks</time_frame>
        <population>safety set</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Rescue Medication During the Treatment Period</title>
          <population>safety set</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any rescue medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any nsH1 - antihistamine rescue medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any clemastine rescue medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any corticosteroid rescue medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Betamethasone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prednisolone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prednisolone succinate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Days of Rescue Medication During the Treatment Period</title>
        <description>data points per group</description>
        <time_frame>baseline to 28 weeks</time_frame>
        <population>safety set</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Days of Rescue Medication During the Treatment Period</title>
          <description>data points per group</description>
          <population>safety set</population>
          <units>days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any rescue medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="507"/>
                    <measurement group_id="O2" value="787"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any nsH1 - antihistamine rescue medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="403"/>
                    <measurement group_id="O2" value="524"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any clemastine rescue medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any corticosteroid rescue medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Days of Rescue Medication During the Follow-up Period</title>
        <description>data points per group</description>
        <time_frame>weeks 33 to 36</time_frame>
        <population>safety set</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Days of Rescue Medication During the Follow-up Period</title>
          <description>data points per group</description>
          <population>safety set</population>
          <units>days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any rescue medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="165"/>
                    <measurement group_id="O2" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any nsH1 - antihistamine rescue medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any clemastine rescue medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any corticosteroid rescue medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)</title>
        <description>The UAS7 is the sum of urticaria activity scores over a seven day period. The possible range of the weekly UAS7 score is 0-42. 0 means complete response and a better outcome and 42 means no response and a worse outcome.&#xD;
Complete UAS7 response is defined as UAS7=0. The UAS7 is the sum of the Hive Severity Score over seven days (HSS7) and the Itch Severity Score over seven days (ISS7) . The Hive Severity Score has a scale of 0 (none) to 3 (intense/severe). Complete hives response is defined as HSS7=0. The Itch Severity Score has a scale of 0 (None) to 3 (Severe (difficult to tolerate)). Complete itch response is defined as ISS7=0</description>
        <time_frame>baseline to week 28; and then follow-up to week 36</time_frame>
        <population>full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)</title>
          <description>The UAS7 is the sum of urticaria activity scores over a seven day period. The possible range of the weekly UAS7 score is 0-42. 0 means complete response and a better outcome and 42 means no response and a worse outcome.&#xD;
Complete UAS7 response is defined as UAS7=0. The UAS7 is the sum of the Hive Severity Score over seven days (HSS7) and the Itch Severity Score over seven days (ISS7) . The Hive Severity Score has a scale of 0 (none) to 3 (intense/severe). Complete hives response is defined as HSS7=0. The Itch Severity Score has a scale of 0 (None) to 3 (Severe (difficult to tolerate)). Complete itch response is defined as ISS7=0</description>
          <population>full analysis set</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.6" spread="13.3"/>
                    <measurement group_id="O2" value="-3.0" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.4" spread="14.3"/>
                    <measurement group_id="O2" value="-4.4" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.0" spread="15.0"/>
                    <measurement group_id="O2" value="-7.2" spread="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.8" spread="14.8"/>
                    <measurement group_id="O2" value="-6.5" spread="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>follow-up, week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.3" spread="15.3"/>
                    <measurement group_id="O2" value="-6.2" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)</title>
        <description>change in Dermatology Quality of Life Index scores&#xD;
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). &quot;Not relevant&quot; is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.</description>
        <time_frame>baseline to week 28; and follow-up to week 36</time_frame>
        <population>full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab once a month via subcutaneous injection.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo of omalizumab once a month via subcutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)</title>
          <description>change in Dermatology Quality of Life Index scores&#xD;
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). &quot;Not relevant&quot; is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.</description>
          <population>full analysis set</population>
          <units>DLQI Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.3" spread="7.3"/>
                    <measurement group_id="O2" value="-2.4" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.1" spread="7.5"/>
                    <measurement group_id="O2" value="-3.9" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.5" spread="8.4"/>
                    <measurement group_id="O2" value="-5.1" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.5" spread="8.3"/>
                    <measurement group_id="O2" value="-5.6" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>follow-up, week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.8" spread="8.6"/>
                    <measurement group_id="O2" value="-5.4" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Omalizumab</title>
          <description>Omalizumab once a month via subcutaneous injection.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo of omalizumab once a month via subcutaneous injection</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Intentional overdose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Ligament injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2.5</frequency_threshold>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="47"/>
              </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="44"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Publications from a single-site are postponed until publication of the pooled clinical trial data (i.e., data from all sites) or disclosure of trial results in their entirety.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>1-888-669-6682</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01723072
org study id: CIGE025EDE16
nct id: NCT01723072
lead sponsor: 
has dmc: No
This study will assess the impact of omalizumab on the quality of life improvement when added
      to the standard therapy in refractory patients suffering from chronic spontaneous urticaria
      and angioedema.
This study will be conducted using a double-blind, placebo-controlled, randomized,
      multicenter design to investigate the impact of omalizumab on Quality of Life (QoL) in
      Chronic Spontaneous Urticaria (CSU) and will assess its effectiveness in reducing and/or
      inhibiting the occurrence, time-course and severity of angioedema episodes.

      Omalizumab is administered subcutaneously every 4 weeks as an add-on therapy to the current
      approved treatment of adult CSU patients. The treatment period is 28 weeks which is followed
      by an 8-week follow-up. The study aims to enroll approximately 70 patients.

      The study is divided into a 2-week screening period, a 28-week double-blind treatment phase
      with omalizumab or placebo-omalizumab, and an 8-week follow-up phase.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS)
time frame: Baseline, 4, 12, 20, 28 and 36 weeks
description: The CU-Q2oL is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It consists of 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Participants are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1= not at all to 5= very much). An overall score is calculated and normalized to a scale of 1 to 100.
measure: Number of Angioedema Burdened Days by Study Phase (Observed Cases With Imputation)
time frame: Baseline, week 28; and the follow-up period (weeks 29-36)
measure: Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes
time frame: Baseline to week 28
measure: Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation)
time frame: Baseline to week 28; and follow-up period (to week 36)
description: A cumulative activity score, evaluated in the screening period and throughout the study. The records each evening on a daily basis symptoms of itch and hives into a patient diary. min. score = 0 ; max. score= 100
measure: Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1)
time frame: week -2 to -1
description: data points per group
measure: Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28)
time frame: weeks 25 to 28
description: data points per group
measure: Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36)
time frame: weeks 33 to 36
description: data points per group
measure: Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1)
time frame: weeks -2 to -1
description: data points per group
measure: Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28)
time frame: weeks 25 to 28
description: data points per group
measure: Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36)
time frame: weeks 33 to 36
description: data points per group
measure: Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)
time frame: baseline to week 28; and then follow-up to week 36
description: The AE-Q2oL is a questionnaire for patients suffering from angioedema. It consists of 29 questions relevant to angioedema and its specific impact on quality of life. Patients are asked to respond how much they are troubled be each problem on a 5-point Likert scale (1= does not apply to 5= very much). An overall score is calculated and a higher score indicates lower quality of life. A negative change score (week 28 score minus baseline score) indicates improvement.
Each AE-QoL question has 5 answer options (scored 1-5), with lower and higher scores indicting less and more adverse impact, respectively. The total score is calculated, which is then transformed into a linear scale that ranges from 0 to 100, with a score of 100 indicating the worst possible impairment of HRQoL
measure: Rescue Medication During the Treatment Period
time frame: baseline to 28 weeks
measure: Days of Rescue Medication During the Treatment Period
time frame: baseline to 28 weeks
description: data points per group
measure: Days of Rescue Medication During the Follow-up Period
time frame: weeks 33 to 36
description: data points per group
measure: Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)
time frame: baseline to week 28; and then follow-up to week 36
description: The UAS7 is the sum of urticaria activity scores over a seven day period. The possible range of the weekly UAS7 score is 0-42. 0 means complete response and a better outcome and 42 means no response and a worse outcome.
Complete UAS7 response is defined as UAS7=0. The UAS7 is the sum of the Hive Severity Score over seven days (HSS7) and the Itch Severity Score over seven days (ISS7) . The Hive Severity Score has a scale of 0 (none) to 3 (intense/severe). Complete hives response is defined as HSS7=0. The Itch Severity Score has a scale of 0 (None) to 3 (Severe (difficult to tolerate)). Complete itch response is defined as ISS7=0
measure: Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)
time frame: baseline to week 28; and follow-up to week 36
description: change in Dermatology Quality of Life Index scores
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.
arm group label: 1 Omalizumab
arm group type: Experimental
description: omalizumab once a month via subcutaneous injection.
arm group label: 2 Placebo
arm group type: Placebo Comparator
description: placebo of omalizumab once a month via subcutaneous injection
intervention type: Biological
intervention name: Omalizumab
description: Humanized monoclonal antibody against human IgE
arm group label: 1 Omalizumab
other name: IGE025
intervention type: Drug
intervention name: Placebo
description: Placebo to omalizumab
arm group label: 2 Placebo
other name: Placebo for Omalizumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
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country: Germany
responsible party type: Sponsor
mesh term: Angioedema
mesh term: Urticaria
mesh term: Chronic Urticaria
mesh term: Omalizumab
mesh term: Antibodies, Monoclonal
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 