<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/NCT01686152</url>
  </required_header>
  <id_info>
    <org_study_id>SYM 2012-01</org_study_id>
    <nct_id>NCT01686152</nct_id>
  </id_info>
  <brief_title>Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis</brief_title>
  <official_title>A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis of the Face or Balding Scalp</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Teva Pharmaceuticals USA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Teva Pharmaceuticals USA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the comparability of the safety and efficacy of Imiquimod Cream, 3.75% and&#xD;
      Zyclara (imiquimod) Cream, 3.75% (the reference listed drug) in subjects with actinic&#xD;
      keratosis (AK) of the face or balding scalp. It will also be determined whether the efficacy&#xD;
      of each of the two active treatments is superior to that of the Vehicle cream.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment Success/Failure at Visit 5/Week 14</measure>
    <time_frame>14 Weeks</time_frame>
    <description>The primary efficacy endpoint is the proportion of subjects with treatment success at Visit 5/Week 14 (8 weeks post-treatment). Treatment success is defined as 100% clearance of all AK lesions (baseline AK lesions and any new AK lesions) within the treatment area.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">589</enrollment>
  <condition>Actinic Keratosis</condition>
  <arm_group>
    <arm_group_label>Investigational Test Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Imiquimod Cream, 3.75% (Teva)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference Listed Drug</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Zyclara® (imiquimod Cream), 3.75% (Medicis)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle of Test Product (Teva)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imiquimod Cream, 3.75%</intervention_name>
    <arm_group_label>Investigational Test Product</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zyclara®</intervention_name>
    <arm_group_label>Reference Listed Drug</arm_group_label>
    <other_name>Imiquimod Cream (generic name)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vehicle of Test Product</intervention_name>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to provide written informed consent for the study&#xD;
&#xD;
          -  At least 18 years of age.&#xD;
&#xD;
          -  Immunocompetent male or non-pregnant and non-lactating female. Each female subject of&#xD;
             childbearing potential (excluding women who are surgically sterilized or&#xD;
             postmenopausal for at least 2 years), in addition to having a negative urine pregnancy&#xD;
             test at Visit 1/Day 1, must be willing to use an acceptable form of birth control&#xD;
             during the study. For the purpose of this study, the following are considered&#xD;
             acceptable methods of birth control: oral contraceptives, contraceptive patches,&#xD;
             contraceptive implant, vaginal contraceptive, double-barrier methods (for example,&#xD;
             condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device&#xD;
             (IUD), hormonal IUD (Mirena®), and abstinence with a documented second acceptable&#xD;
             method of birth control if the subject becomes sexually active. Subjects entering the&#xD;
             study who are on hormonal contraceptives (oral contraceptives, patches and injection)&#xD;
             must have been on this method for at least 3 months (90 days) prior to the study and&#xD;
             continue the method for the duration of the study. Subjects who had used hormonal&#xD;
             contraception (oral contraceptives, patches and injection) and stopped must have&#xD;
             stopped no less than 3 months (90 days) prior to baseline. Subjects entering the study&#xD;
             using contraceptive implants and intrauterine contraceptives must have been on this&#xD;
             method for at least 6 months (180 days) and continue for the duration of the study and&#xD;
             if they stopped must have stopped no less than 6 months (180 days) prior to baseline.&#xD;
&#xD;
          -  Clinical diagnosis of AK, defined as ≥ 5 and ≤ 20 clinically typical, visible or&#xD;
             palpable AK lesions, each at least 4 mm in diameter, in an area that exceeds 25 cm2 on&#xD;
             either the face (excluding ears) or balding scalp, but not both face and scalp.&#xD;
&#xD;
          -  In general good health and free from any clinically significant disease, other than&#xD;
             AK, that might interfere with the study evaluations.&#xD;
&#xD;
          -  Willing and able to understand and comply with the requirements of the study, apply&#xD;
             the IP as instructed, attend the required visits, comply with therapy prohibitions,&#xD;
             and be able to complete the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea,&#xD;
             squamous cell carcinoma, or other possible confounding skin conditions on the&#xD;
             treatment area of either the face or balding scalp.&#xD;
&#xD;
          -  Clinically significant systemic disease (immunological deficiencies), unstable medical&#xD;
             disorder, life-threatening disease, or current malignancies.&#xD;
&#xD;
          -  Use on the face or balding scalp of chemical peel, dermabrasion, laser abrasion,&#xD;
             psoralen plus ultraviolet A (PUVA) therapy, and/or ultraviolet B (UVB) therapy in the&#xD;
             last 6 months (180 days)&#xD;
&#xD;
          -  Use of any systemic cancer chemotherapy medications in the last 6 months (180 days)&#xD;
&#xD;
          -  Use on the face or balding scalp of cryodestruction or chemodestruction, curettage,&#xD;
             photodynamic therapy, surgical excision, topical 5-fluorouracil, topical&#xD;
             corticosteroids, topical diclofenac, topical imiquimod, topical retinoids, masoprocol,&#xD;
             or other treatments for AK in the last 1 month (30 days)&#xD;
&#xD;
          -  Immunomodulators or immunosuppressive therapies, interferon, oral/systemic&#xD;
             corticosteroids, or cytotoxic drugs in the last 1 month (30 days). Intranasal or&#xD;
             inhaled corticosteroids are acceptable if kept constant throughout the study.&#xD;
&#xD;
          -  Need or intent to continue to use any treatment listed in the four points above during&#xD;
             the current study&#xD;
&#xD;
          -  Known hypersensitivity or allergies to imiquimod or any component of the IP (in any&#xD;
             dosage form).&#xD;
&#xD;
          -  Females who are pregnant, breastfeeding, intending to become pregnant during the&#xD;
             study, or who do not agree to use an acceptable form of birth control during the&#xD;
             study.&#xD;
&#xD;
          -  Any clinically significant condition or situation other than the condition being&#xD;
             studied that, in the opinion of the investigator, would interfere with the study&#xD;
             evaluations or optimal participation in the study.&#xD;
&#xD;
          -  Use of any investigational drug or investigational device within 1 month (30 days)&#xD;
             prior to randomization.&#xD;
&#xD;
          -  Previous participation in this study.&#xD;
&#xD;
          -  Sunburn in the designated treatment area to be treated at study entry.&#xD;
&#xD;
          -  Current involvement in activities that require excessive or prolonged sun exposure.&#xD;
&#xD;
          -  Consumption of excessive amounts of alcohol, abuse drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Encino Research Center</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Research Associates</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern California Research</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Surgery Medical Group, Inc.</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Longmont Clinic, PC</name>
      <address>
        <city>Longmont</city>
        <state>Colorado</state>
        <zip>80501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visions Clinical Research</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa Bay Medical Research</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacksonville Center for Clinical Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Dermatology Research, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tory Sullivan, M.D., P.A.</name>
      <address>
        <city>North Miami Beach</city>
        <state>Florida</state>
        <zip>33162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Park Avenue Dermatology, PA</name>
      <address>
        <city>Orange Park</city>
        <state>Florida</state>
        <zip>32073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leavitt Medical Associates of Florida dba Ameriderm Research</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedaPhase, Inc.</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>30263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altman Dermatology Associates</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Indiana Clinical Trials Center</name>
      <address>
        <city>Plainfield</city>
        <state>Indiana</state>
        <zip>46168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Specialists Research LLC</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Medical Research Center, PC</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97223</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Philadelphia Institute of Dermatology</name>
      <address>
        <city>Fort Washington</city>
        <state>Pennsylvania</state>
        <zip>19034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Medical Research</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Across America</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2012</study_first_posted>
  <results_first_submitted>October 7, 2020</results_first_submitted>
  <results_first_submitted_qc>October 7, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 30, 2020</results_first_posted>
  <last_update_submitted>November 6, 2020</last_update_submitted>
  <last_update_submitted_qc>November 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratosis, Actinic</mesh_term>
    <mesh_term>Keratosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Imiquimod</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Investigational Test Product</title>
          <description>Imiquimod Cream, 3.75% (Teva)</description>
        </group>
        <group group_id="P2">
          <title>Reference Listed Drug</title>
          <description>Zyclara® (imiquimod Cream), 3.75% (Medicis)</description>
        </group>
        <group group_id="P3">
          <title>Vehicle</title>
          <description>Vehicle of Test Product (Teva)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="252"/>
                <participants group_id="P2" count="253"/>
                <participants group_id="P3" count="84"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="211"/>
                <participants group_id="P2" count="218"/>
                <participants group_id="P3" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Drug Code Unblinded</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>IP Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population Data Included</population>
      <group_list>
        <group group_id="B1">
          <title>Investigational Test Product</title>
          <description>Imiquimod Cream, 3.75% (Teva)</description>
        </group>
        <group group_id="B2">
          <title>Reference Listed Drug</title>
          <description>Zyclara® (imiquimod Cream), 3.75% (Medicis)</description>
        </group>
        <group group_id="B3">
          <title>Vehicle</title>
          <description>Vehicle of Test Product (Teva)</description>
        </group>
        <group group_id="B4">
          <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="247"/>
            <count group_id="B2" value="249"/>
            <count group_id="B3" value="80"/>
            <count group_id="B4" value="576"/>
          </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="67.8" spread="9.12"/>
                    <measurement group_id="B2" value="68.6" spread="9.79"/>
                    <measurement group_id="B3" value="68.7" spread="10.23"/>
                    <measurement group_id="B4" value="68.3" spread="9.57"/>
                  </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="44"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="203"/>
                    <measurement group_id="B2" value="222"/>
                    <measurement group_id="B3" value="67"/>
                    <measurement group_id="B4" value="492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="237"/>
                    <measurement group_id="B2" value="237"/>
                    <measurement group_id="B3" value="78"/>
                    <measurement group_id="B4" value="552"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="246"/>
                    <measurement group_id="B2" value="249"/>
                    <measurement group_id="B3" value="80"/>
                    <measurement group_id="B4" value="575"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Location of Lesion</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Scalp</title>
                  <measurement_list>
                    <measurement group_id="B1" value="115"/>
                    <measurement group_id="B2" value="135"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="285"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Face</title>
                  <measurement_list>
                    <measurement group_id="B1" value="132"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Size (cm^2) of Lesion</title>
          <units>cm2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="317.5" spread="178.53"/>
                    <measurement group_id="B2" value="305.8" spread="180.78"/>
                    <measurement group_id="B3" value="335.7" spread="183.78"/>
                    <measurement group_id="B4" value="315" spread="180.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Visible or Palpable Lesions</title>
          <units>lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.6" spread="3.98"/>
                    <measurement group_id="B2" value="10.7" spread="4.16"/>
                    <measurement group_id="B3" value="11.0" spread="4.35"/>
                    <measurement group_id="B4" value="10.7" spread="4.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment Success/Failure at Visit 5/Week 14</title>
        <description>The primary efficacy endpoint is the proportion of subjects with treatment success at Visit 5/Week 14 (8 weeks post-treatment). Treatment success is defined as 100% clearance of all AK lesions (baseline AK lesions and any new AK lesions) within the treatment area.</description>
        <time_frame>14 Weeks</time_frame>
        <population>Per-Protocol Population</population>
        <group_list>
          <group group_id="O1">
            <title>Investigational Test Product</title>
            <description>Imiquimod Cream, 3.75% (Teva)</description>
          </group>
          <group group_id="O2">
            <title>Reference Listed Drug</title>
            <description>Zyclara® (imiquimod Cream), 3.75% (Medicis)</description>
          </group>
          <group group_id="O3">
            <title>Vehicle</title>
            <description>Vehicle of Test Product (Teva)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Success/Failure at Visit 5/Week 14</title>
          <description>The primary efficacy endpoint is the proportion of subjects with treatment success at Visit 5/Week 14 (8 weeks post-treatment). Treatment success is defined as 100% clearance of all AK lesions (baseline AK lesions and any new AK lesions) within the treatment area.</description>
          <population>Per-Protocol Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
                <count group_id="O2" value="179"/>
                <count group_id="O3" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Success (100% clearance of AK lesions)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Failure &lt;100% clearance of AK lesions</title>
                  <measurement_list>
                    <measurement group_id="O1" value="136"/>
                    <measurement group_id="O2" value="139"/>
                    <measurement group_id="O3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The test product was determined to be bioequivalent to the reference product if the 90% confidence interval was within -0.20 to 0.20.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.05</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0663</ci_lower_limit>
            <ci_upper_limit>0.0913</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Investigational Test Product</title>
          <description>Imiquimod Cream, 3.75% (Teva)</description>
        </group>
        <group group_id="E2">
          <title>Reference Listed Drug</title>
          <description>Zyclara® (imiquimod Cream), 3.75% (Medicis)</description>
        </group>
        <group group_id="E3">
          <title>Vehicle</title>
          <description>Vehicle of Test Product (Teva)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic Gastroparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis Ischemic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Viral Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Laceration (scalp)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Ligament Rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Umbilical Hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="81" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="77" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cardiomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Eye Irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Eye Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Eyelid Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lacrimation Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ocular Hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Retinal Tear</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Colitis Ischaemic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Colonic Polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diabetic Gastroparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal Reflux Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gingival Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lip Erosion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lip Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lip Swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oral Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pancreatic Cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Umbilical Hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application Site Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Application Site Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Application Site Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Application Site Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Application Site Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Application Site Reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chest Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Influenza Like Illness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Local Swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oedema Mucosal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tenderness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatic Steatosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to Arthropod Sting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Adenoviral Upper Respiratory Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Application Site Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Application Site Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bacterial Infections</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dental Fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastroenteritis Viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oral Herpes</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash Pustular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Staphylococcal Skin Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tooth Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Viral Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod Bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Epicondylitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Foreign Body</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ligament Rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Muscle Strain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Procedural Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin Injuries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Superficial Injury of Eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </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="3" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Keratoacanthoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Malignant Melanoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Prostate Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin Papilloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Squamous Cell Carcinoma of Skin</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Disorientation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nightmare</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Renal Failure Acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Productive Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Upper-Airway Cough Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Actinic Keratosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Drug Eruption</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hair Growth Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lichen Sclerosus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pruritus Generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin Erosion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="249"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="80"/>
              </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>PIs may not publish results from this generic (ANDA) study unless reviewed and approved by sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director, PD/CE Studies</name_or_title>
      <organization>Teva Pharmaceuticals USA</organization>
      <phone>1-888-483-8279</phone>
      <email>usmedinfo@tevapharm.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01686152
org study id: SYM 2012-01
nct id: NCT01686152
lead sponsor: 
has dmc: No
To determine the comparability of the safety and efficacy of Imiquimod Cream, 3.75% and
      Zyclara (imiquimod) Cream, 3.75% (the reference listed drug) in subjects with actinic
      keratosis (AK) of the face or balding scalp. It will also be determined whether the efficacy
      of each of the two active treatments is superior to that of the Vehicle cream.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Treatment Success/Failure at Visit 5/Week 14
time frame: 14 Weeks
description: The primary efficacy endpoint is the proportion of subjects with treatment success at Visit 5/Week 14 (8 weeks post-treatment). Treatment success is defined as 100% clearance of all AK lesions (baseline AK lesions and any new AK lesions) within the treatment area.
arm group label: Investigational Test Product
arm group type: Experimental
description: Imiquimod Cream, 3.75% (Teva)
arm group label: Reference Listed Drug
arm group type: Active Comparator
description: Zyclara® (imiquimod Cream), 3.75% (Medicis)
arm group label: Vehicle
arm group type: Placebo Comparator
description: Vehicle of Test Product (Teva)
intervention type: Drug
intervention name: Imiquimod Cream, 3.75%
arm group label: Investigational Test Product
intervention type: Drug
intervention name: Zyclara®
arm group label: Reference Listed Drug
other name: Imiquimod Cream (generic name)
intervention type: Other
intervention name: Vehicle of Test Product
arm group label: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Keratosis, Actinic
mesh term: Keratosis
mesh term: Imiquimod
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 