<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/NCT01672983</url>
  </required_header>
  <id_info>
    <org_study_id>M12-536</org_study_id>
    <nct_id>NCT01672983</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection</brief_title>
  <official_title>A Phase 2 Study to Evaluate the Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie (prior sponsor, Abbott)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of&#xD;
      ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as&#xD;
      ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b)&#xD;
      or genotype 2 (HCV GT2) infection who were previous treated with pegylated&#xD;
      interferon/ribavirin (pegIFN/RBV).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multicenter, randomized, open-label, parallel-arm, combination treatment study consisted&#xD;
      of a Treatment and Post-treatment Phase, divided into 2 cohorts: 1) chronic HCV GT1b-&#xD;
      infected, pegIFN/RBV treatment-exposed Japanese adults; and 2) HCV GT2-infected, pegIFN/RBV&#xD;
      treatment-exposed Japanese adults. The Treatment Phase evaluated the antiviral activity,&#xD;
      safety, and pharmacokinetics of a range of ABT-450/r and ABT-267 doses for 12 to 24 weeks.&#xD;
      The Post-treatment Phase evaluated the evolution and persistence of viral resistance to&#xD;
      ABT-267 and ABT-450.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)</measure>
    <time_frame>24 weeks after last dose of study drug</time_frame>
    <description>The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [&lt; LLOQ] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.</time_frame>
    <description>An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12)</measure>
    <time_frame>12 weeks after last dose of study drug</time_frame>
    <description>The percentage of participants with SVR12 (plasma HCV RNA level &lt; LLOQ 12 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With End of Treatment (EOT) Response</measure>
    <time_frame>12 or 24 weeks after first dose of study drug</time_frame>
    <description>The percentage of participants with EOT response (plasma HCV RNA level &lt; LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12). The LLOQ for the assay was 25 IU/mL.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Chronic Hepatitis C Infection</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-450/ritonavir, ABT-267</intervention_name>
    <description>ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_label>Arm 4</arm_group_label>
    <arm_group_label>Arm 5</arm_group_label>
    <arm_group_label>Arm 6</arm_group_label>
    <other_name>ABT-450 also known as paritaprevir</other_name>
    <other_name>ABT-267 also known as ombitasvir</other_name>
    <other_name>ritonavir also known as Norvir</other_name>
    <other_name>ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females must be practicing specific forms of birth control on study treatment, or be&#xD;
             post-menopausal for more than 2 years or surgically sterile&#xD;
&#xD;
          -  Chronic hepatitis C, genotype 1b (HCV-GT1b) or genotype 2 (HCV GT2) infection (HCV RNA&#xD;
             level greater than 10,000 IU/mL at screening) previously treated with pegylated&#xD;
             interferon/ribavirin (pegIFN/RBV).&#xD;
&#xD;
          -  Subject's hepatitis C virus genotype is subgenotype 1b and subject was a null&#xD;
             responder or partial responder, OR&#xD;
&#xD;
          -  Subject's hepatitis C virus genotype is subgenotype 2 and subject was a null&#xD;
             responder, partial responder, or relapser (Null responder: received at least 10 weeks&#xD;
             of pegIFN/RBV for the treatment of HCV and failed to achieve a 2 log10 IU/mL reduction&#xD;
             in HCV RNA at Week 12; Partial responders: received at least 20 weeks of pegIFN/RBV&#xD;
             for the treatment of HCV and achieved ≥ 2 log10 IU/mL reduction in HCV RNA at Week 12,&#xD;
             but failed to achieve HCV RNA undetectable (HCV RNA &lt; lower limit of detection [&lt;&#xD;
             LLOD]) at the end of treatment; Relapsers: received at least 1 course of pegIFN/RBV&#xD;
             for the treatment of HCV and was undetectable at the end of treatment, but HCV RNA was&#xD;
             detectable within 24 weeks of treatment follow-up).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant liver disease with any cause other than HCV as the primary cause&#xD;
&#xD;
          -  Positive screen for drugs or alcohol.&#xD;
&#xD;
          -  Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.&#xD;
&#xD;
          -  Use of contraindicated medications within 2 weeks of dosing&#xD;
&#xD;
          -  Previous use of any investigational or commercially available anti-Hepatitis C virus&#xD;
             agent other than pegIFN/RBV, including previous exposure to ABT-450 or ABT-267.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Takuma Matsuda, MS</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie GK.</affiliation>
  </overall_official>
  <removed_countries>
    <country>Japan</country>
  </removed_countries>
  <link>
    <url>http://rxabbvie.com</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Chayama K, Notsumata K, Kurosaki M, Sato K, Rodrigues L Jr, Setze C, Badri P, Pilot-Matias T, Vilchez RA, Kumada H. Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced hepatitis C virus-infected patients. Hepatology. 2015 May;61(5):1523-32. doi: 10.1002/hep.27705. Epub 2015 Mar 23.</citation>
    <PMID>25644279</PMID>
  </results_reference>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>October 27, 2015</results_first_submitted>
  <results_first_submitted_qc>October 27, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 26, 2015</results_first_posted>
  <last_update_submitted>April 30, 2018</last_update_submitted>
  <last_update_submitted_qc>April 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Japanese</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>Genotype 2</keyword>
  <keyword>Genotype 1b</keyword>
  <keyword>paritaprevir</keyword>
  <keyword>ombitasvir</keyword>
  <keyword>ritonavir</keyword>
  <keyword>VIEKIRAX Combination Tablets</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Arm 1</title>
          <description>Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Arm 2</title>
          <description>Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Arm 3</title>
          <description>Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.</description>
        </group>
        <group group_id="P4">
          <title>Arm 4</title>
          <description>Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.</description>
        </group>
        <group group_id="P5">
          <title>Arm 5</title>
          <description>Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
        </group>
        <group group_id="P6">
          <title>Arm 6</title>
          <description>Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="18"/>
                <participants group_id="P5" count="19"/>
                <participants group_id="P6" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="18"/>
                <participants group_id="P4" count="18"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="18"/>
                <participants group_id="P5" count="19"/>
                <participants group_id="P6" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics were summarized by treatment arm for all participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Arm 1</title>
          <description>Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Arm 2</title>
          <description>Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Arm 3</title>
          <description>Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.</description>
        </group>
        <group group_id="B4">
          <title>Arm 4</title>
          <description>Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.</description>
        </group>
        <group group_id="B5">
          <title>Arm 5</title>
          <description>Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
        </group>
        <group group_id="B6">
          <title>Arm 6</title>
          <description>Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
        </group>
        <group group_id="B7">
          <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="18"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="19"/>
            <count group_id="B4" value="18"/>
            <count group_id="B5" value="19"/>
            <count group_id="B6" value="18"/>
            <count group_id="B7" value="110"/>
          </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="55.3" spread="15.06"/>
                    <measurement group_id="B2" value="54.8" spread="11.96"/>
                    <measurement group_id="B3" value="61.9" spread="8.14"/>
                    <measurement group_id="B4" value="57.5" spread="10.15"/>
                    <measurement group_id="B5" value="62.5" spread="8.34"/>
                    <measurement group_id="B6" value="62.8" spread="7.89"/>
                    <measurement group_id="B7" value="59.2" spread="10.84"/>
                  </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="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="12"/>
                    <measurement group_id="B6" value="10"/>
                    <measurement group_id="B7" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)</title>
        <description>The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [&lt; LLOQ] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.</description>
        <time_frame>24 weeks after last dose of study drug</time_frame>
        <population>Intent-to-treat (ITT) population: all subjects who received at least 1 dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1</title>
            <description>Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2</title>
            <description>Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3</title>
            <description>Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Arm 4</title>
            <description>Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Arm 5</title>
            <description>Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Arm 6</title>
            <description>Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)</title>
          <description>The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [&lt; LLOQ] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.</description>
          <population>Intent-to-treat (ITT) population: all subjects who received at least 1 dose of study drug</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="19"/>
                <count group_id="O6" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="81.47" upper_limit="100.00"/>
                    <measurement group_id="O2" value="88.9" lower_limit="65.29" upper_limit="98.62"/>
                    <measurement group_id="O3" value="100" lower_limit="82.35" upper_limit="100.00"/>
                    <measurement group_id="O4" value="100" lower_limit="81.47" upper_limit="100.00"/>
                    <measurement group_id="O5" value="57.9" lower_limit="33.50" upper_limit="79.75"/>
                    <measurement group_id="O6" value="72.2" lower_limit="46.52" upper_limit="90.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events (AEs)</title>
        <description>An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.</description>
        <time_frame>TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.</time_frame>
        <population>Safety population: all participants who received at least 1 dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1 + Arm 5</title>
            <description>Arm 1: Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks; Arm 5: Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2 + Arm 6</title>
            <description>Arm 2: Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks; Arm 6: Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3</title>
            <description>Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Arm 4</title>
            <description>Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs)</title>
          <description>An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.</description>
          <population>Safety population: all participants who received at least 1 dose of study drug</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12)</title>
        <description>The percentage of participants with SVR12 (plasma HCV RNA level &lt; LLOQ 12 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.</description>
        <time_frame>12 weeks after last dose of study drug</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1</title>
            <description>Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2</title>
            <description>Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3</title>
            <description>Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Arm 4</title>
            <description>Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Arm 5</title>
            <description>Hepatitis C Virus (HCV), genotype 2 (GT2) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Arm 6</title>
            <description>Hepatitis C Virus (HCV), genotype 2 (GT2) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12)</title>
          <description>The percentage of participants with SVR12 (plasma HCV RNA level &lt; LLOQ 12 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.</description>
          <population>ITT population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="19"/>
                <count group_id="O6" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="81.47" upper_limit="100.00"/>
                    <measurement group_id="O2" value="88.9" lower_limit="65.29" upper_limit="98.62"/>
                    <measurement group_id="O3" value="100" lower_limit="82.35" upper_limit="100.00"/>
                    <measurement group_id="O4" value="100" lower_limit="81.47" upper_limit="100.00"/>
                    <measurement group_id="O5" value="57.9" lower_limit="33.50" upper_limit="79.75"/>
                    <measurement group_id="O6" value="72.2" lower_limit="46.52" upper_limit="90.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With End of Treatment (EOT) Response</title>
        <description>The percentage of participants with EOT response (plasma HCV RNA level &lt; LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12). The LLOQ for the assay was 25 IU/mL.</description>
        <time_frame>12 or 24 weeks after first dose of study drug</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1</title>
            <description>Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2</title>
            <description>Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3</title>
            <description>Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Arm 4</title>
            <description>Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Arm 5</title>
            <description>Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Arm 6</title>
            <description>Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With End of Treatment (EOT) Response</title>
          <description>The percentage of participants with EOT response (plasma HCV RNA level &lt; LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12). The LLOQ for the assay was 25 IU/mL.</description>
          <population>ITT population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="19"/>
                <count group_id="O6" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="81.47" upper_limit="100.00"/>
                    <measurement group_id="O2" value="100" lower_limit="81.47" upper_limit="100.00"/>
                    <measurement group_id="O3" value="100" lower_limit="82.35" upper_limit="100.00"/>
                    <measurement group_id="O4" value="100" lower_limit="81.47" upper_limit="100.00"/>
                    <measurement group_id="O5" value="63.2" lower_limit="38.36" upper_limit="83.71"/>
                    <measurement group_id="O6" value="83.3" lower_limit="58.58" upper_limit="96.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks).</time_frame>
      <desc>TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).</desc>
      <group_list>
        <group group_id="E1">
          <title>Arm 1</title>
          <description>Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Arm 2</title>
          <description>Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Arm 3</title>
          <description>Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.</description>
        </group>
        <group group_id="E4">
          <title>Arm 4</title>
          <description>Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.</description>
        </group>
        <group group_id="E5">
          <title>Arm 5</title>
          <description>Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
        </group>
        <group group_id="E6">
          <title>Arm 6</title>
          <description>Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>COLITIS ISCHAEMIC</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>AUTOIMMUNE HEPATITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>FEMUR FRACTURE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>TIBIA FRACTURE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>FLUID RETENTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.1</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="14" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="14" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>HYPOCHROMIC ANAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEUKOCYTOSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LEUKOPENIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>NEUTROPENIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>NEUTROPHILIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PALPITATIONS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>TACHYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>VENTRICULAR EXTRASYSTOLES</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>SUDDEN HEARING LOSS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENOPIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>BLEPHARITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CHALAZION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CONJUNCTIVITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DIPLOPIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DRY EYE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PUNCTATE KERATITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>STRABISMUS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </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="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DENTAL CARIES</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DUODENAL ULCER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ENTERITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ENTEROCOLITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>GASTRITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>GASTROOESOPHAGEAL REFLUX DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>GINGIVAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>GLOSSODYNIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RADICULAR CYST</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>STOMATITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>CHEST DISCOMFORT</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>MALAISE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>OEDEMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>BILIARY COLIC</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CHOLELITHIASIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>SEASONAL ALLERGY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CYSTITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS BACTERIAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS VIRAL</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>GINGIVITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>HELICOBACTER GASTRITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PERIODONTITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>ANIMAL BITE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ARTHROPOD STING</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CONTUSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PROCEDURAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>BLOOD ALKALINE PHOSPHATASE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>BLOOD BILIRUBIN INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>BLOOD BILIRUBIN UNCONJUGATED INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>BLOOD CREATININE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>BLOOD GLUCOSE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>BLOOD PRESSURE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CREATININE RENAL CLEARANCE DECREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>HAEMOGLOBIN DECREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>LYMPHOCYTE COUNT DECREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>NEUTROPHIL COUNT DECREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PROTEIN URINE PRESENT</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>URINE LEUKOCYTE ESTERASE POSITIVE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>WHITE BLOOD CELL COUNT DECREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DIABETES MELLITUS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>HYPERLIPIDAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>HYPOKALAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>FLANK PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INTERVERTEBRAL DISC PROTRUSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>JOINT SWELLING</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>MUSCLE SPASMS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL STIFFNESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>MYOFASCIAL PAIN SYNDROME</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>SPINAL OSTEOARTHRITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>AUTONOMIC NERVOUS SYSTEM IMBALANCE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CERVICAL RADICULOPATHY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>HEAD DISCOMFORT</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>MIGRAINE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>SOMNOLENCE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DYSPHORIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>HAEMATURIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>NOCTURIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PROTEINURIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>OROPHARYNGEAL DISCOMFORT</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>OROPHARYNGEAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFLAMMATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ALOPECIA AREATA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>CUTANEOUS LUPUS ERYTHEMATOSUS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DERMATITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>DERMATITIS ALLERGIC</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ECZEMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>ERYTHEMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>HYPERHIDROSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>SKIN EXFOLIATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </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="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>HOT FLUSH</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="18"/>
              </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>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Information</name_or_title>
      <organization>AbbVie (prior sponsor, Abbott)</organization>
      <phone>800-633-9110</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01672983
org study id: M12-536
nct id: NCT01672983
lead sponsor: 
has dmc: No
This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of
      ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as
      ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b)
      or genotype 2 (HCV GT2) infection who were previous treated with pegylated
      interferon/ribavirin (pegIFN/RBV).
This multicenter, randomized, open-label, parallel-arm, combination treatment study consisted
      of a Treatment and Post-treatment Phase, divided into 2 cohorts: 1) chronic HCV GT1b-
      infected, pegIFN/RBV treatment-exposed Japanese adults; and 2) HCV GT2-infected, pegIFN/RBV
      treatment-exposed Japanese adults. The Treatment Phase evaluated the antiviral activity,
      safety, and pharmacokinetics of a range of ABT-450/r and ABT-267 doses for 12 to 24 weeks.
      The Post-treatment Phase evaluated the evolution and persistence of viral resistance to
      ABT-267 and ABT-450.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)
time frame: 24 weeks after last dose of study drug
description: The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.
measure: Number of Participants With Adverse Events (AEs)
time frame: TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.
description: An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12)
time frame: 12 weeks after last dose of study drug
description: The percentage of participants with SVR12 (plasma HCV RNA level < LLOQ 12 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.
measure: Percentage of Participants With End of Treatment (EOT) Response
time frame: 12 or 24 weeks after first dose of study drug
description: The percentage of participants with EOT response (plasma HCV RNA level < LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12). The LLOQ for the assay was 25 IU/mL.
arm group label: Arm 1
arm group type: Experimental
description: Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
arm group label: Arm 2
arm group type: Experimental
description: Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
arm group label: Arm 3
arm group type: Experimental
description: Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
arm group label: Arm 4
arm group type: Experimental
description: Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
arm group label: Arm 5
arm group type: Experimental
description: Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
arm group label: Arm 6
arm group type: Experimental
description: Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
intervention type: Drug
intervention name: ABT-450/ritonavir, ABT-267
description: ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
arm group label: Arm 1
arm group label: Arm 2
arm group label: Arm 3
arm group label: Arm 4
arm group label: Arm 5
arm group label: Arm 6
other name: ABT-450 also known as paritaprevir
other name: ABT-267 also known as ombitasvir
other name: ritonavir also known as Norvir
other name: ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Takuma Matsuda, MS
role: Study Director
affiliation: AbbVie GK.
country: Japan
url: http://rxabbvie.com
description: Related Info
citation: Chayama K, Notsumata K, Kurosaki M, Sato K, Rodrigues L Jr, Setze C, Badri P, Pilot-Matias T, Vilchez RA, Kumada H. Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced hepatitis C virus-infected patients. Hepatology. 2015 May;61(5):1523-32. doi: 10.1002/hep.27705. Epub 2015 Mar 23.
PMID: 25644279
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Virus Diseases
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Ritonavir
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 