<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/NCT03015532</url>
  </required_header>
  <id_info>
    <org_study_id>HTX-011-209</org_study_id>
    <nct_id>NCT03015532</nct_id>
  </id_info>
  <brief_title>Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia</brief_title>
  <official_title>A Phase 2b, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study of HTX-011 Via Infiltration for Postoperative Analgesia in Subjects Undergoing Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heron Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heron Therapeutics</source>
  <brief_summary>
    <textblock>
      This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled,&#xD;
      multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to&#xD;
      evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered&#xD;
      via infiltration to the surgical site.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2017</start_date>
  <completion_date type="Actual">May 16, 2018</completion_date>
  <primary_completion_date type="Actual">April 20, 2018</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores</measure>
    <time_frame>48 hours</time_frame>
    <description>Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. NRS scores are recorded at rest (NRS-R).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores</measure>
    <time_frame>72 hours</time_frame>
    <description>Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. NRS scores are recorded at rest (NRS-R).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)</measure>
    <time_frame>72 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">285</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Cohort 1, Group 1: HTX-011</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1, Group 2: HTX-011</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1, Group 3: Saline Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline placebo via injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1, Group 4: Bupivacaine HCI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine HCl without epinephrine, 125 mg via injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2, Group 1: HTX-011</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2, Group 2: HTX-011 + Ropivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2, Group 3: Saline Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline placebo via injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2, Group 4: Bupivacaine HCI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine HCl without epinephrine, 125 mg via injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HTX-011</intervention_name>
    <description>HTX-011 (bupivacaine/meloxicam), via instillation</description>
    <arm_group_label>Cohort 1, Group 1: HTX-011</arm_group_label>
    <arm_group_label>Cohort 1, Group 2: HTX-011</arm_group_label>
    <arm_group_label>Cohort 2, Group 1: HTX-011</arm_group_label>
    <arm_group_label>Cohort 2, Group 2: HTX-011 + Ropivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline Placebo</intervention_name>
    <description>Saline placebo via injection</description>
    <arm_group_label>Cohort 1, Group 3: Saline Placebo</arm_group_label>
    <arm_group_label>Cohort 2, Group 3: Saline Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivicaine HCl</intervention_name>
    <description>Bupivacaine HCl without epinephrine</description>
    <arm_group_label>Cohort 1, Group 4: Bupivacaine HCI</arm_group_label>
    <arm_group_label>Cohort 2, Group 4: Bupivacaine HCI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Ropivacaine, via injection</description>
    <arm_group_label>Cohort 2, Group 2: HTX-011 + Ropivacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is scheduled to undergo primary unilateral TKA under general anesthesia.&#xD;
&#xD;
          -  Has not previously undergone TKA in either knee.&#xD;
&#xD;
          -  Has an American Society of Anesthesiologists Physical Status of I, II, or III.&#xD;
&#xD;
          -  Is able to demonstrate motor function by performing a timed 20-meter walk unassisted,&#xD;
             but with the optional use of a 4-legged walker for balance.&#xD;
&#xD;
          -  Female subjects are eligible only if not pregnant, not lactating, not planning to&#xD;
             become pregnant during the study, sterile; or using acceptable contraceptives.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a planned concurrent surgical procedure (eg, bilateral TKA).&#xD;
&#xD;
          -  Has a pre-existing concurrent acute or chronic painful/restrictive physical condition&#xD;
             that may require analgesic treatment in the postoperative period for pain.&#xD;
&#xD;
          -  Has a contraindication or a known or suspected history of hypersensitivity or&#xD;
             idiosyncratic reaction to required study medications.&#xD;
&#xD;
          -  Has known or suspected daily use of opioids for 7 or more consecutive days within the&#xD;
             previous 6 months.&#xD;
&#xD;
          -  Has taken NSAIDs within 10 days prior to the scheduled surgery.&#xD;
&#xD;
          -  Has taken opioids within 24 hours prior to the scheduled surgery (3 days for&#xD;
             long-acting).&#xD;
&#xD;
          -  Has been administered bupivacaine within 5 days prior to the scheduled surgery.&#xD;
&#xD;
          -  Has initiated treatment with medications within 1 month prior to study drug&#xD;
             administration that can impact pain control.&#xD;
&#xD;
          -  Has been administered systemic steroids within 5 half-lives or 10 days prior to&#xD;
             administration of study drug.&#xD;
&#xD;
          -  Has a medical condition such that, in the opinion of the Investigator, participating&#xD;
             in the study would pose a health risk to the subject or confound the postoperative&#xD;
             assessments.&#xD;
&#xD;
          -  Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active&#xD;
             Hepatitis C.&#xD;
&#xD;
          -  Has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere&#xD;
             with study assessments.&#xD;
&#xD;
          -  Has any chronic neuromuscular deficit of either femoral nerve function or thigh&#xD;
             musculature. Has any chronic condition or disease that would compromise neurological&#xD;
             or vascular assessments.&#xD;
&#xD;
          -  Had a malignancy in the last year, with the exception of non-metastatic basal cell or&#xD;
             squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.&#xD;
&#xD;
          -  Has a known or suspected history of drug abuse, a positive drug screen on the day of&#xD;
             surgery, or a recent history of alcohol abuse.&#xD;
&#xD;
          -  Received an investigational product or device in a clinical trial within 30 days or&#xD;
             within 5 elimination half lives.&#xD;
&#xD;
          -  Has undergone 3 or more surgeries within 12 months.&#xD;
&#xD;
          -  Has a body mass index (BMI) &gt;38 kg/m2.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sheffield</city>
        <state>Alabama</state>
        <zip>35660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <results_first_submitted>June 11, 2021</results_first_submitted>
  <results_first_submitted_qc>September 29, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 27, 2021</results_first_posted>
  <disposition_first_submitted>June 8, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>June 8, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 12, 2018</disposition_first_posted>
  <last_update_submitted>September 29, 2021</last_update_submitted>
  <last_update_submitted_qc>September 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>knee</keyword>
  <keyword>knee replacement</keyword>
  <keyword>arthroplasty</keyword>
  <keyword>joint replacement</keyword>
  <keyword>knee pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03015532/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03015532/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1, Group 1: HTX-011</title>
          <description>HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 1, Group 2: HTX-011</title>
          <description>HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).</description>
        </group>
        <group group_id="P3">
          <title>Cohort 1, Group 3: Saline Placebo</title>
          <description>Saline placebo via injection.</description>
        </group>
        <group group_id="P4">
          <title>Cohort 1, Group 4: Bupivacaine HCI</title>
          <description>Bupivacaine HCl without epinephrine, 125 mg via injection.</description>
        </group>
        <group group_id="P5">
          <title>Cohort 2, Group 1: HTX-011</title>
          <description>HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.</description>
        </group>
        <group group_id="P6">
          <title>Cohort 2, Group 2: HTX-011 + Ropivacaine</title>
          <description>HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.</description>
        </group>
        <group group_id="P7">
          <title>Cohort 2, Group 3: Saline Placebo</title>
          <description>Saline placebo via injection.</description>
        </group>
        <group group_id="P8">
          <title>Cohort 2, Group 4: Bupivacaine HCI</title>
          <description>Bupivacaine HCl without epinephrine, 125 mg via injection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="58"/>
                <participants group_id="P6" count="56"/>
                <participants group_id="P7" count="53"/>
                <participants group_id="P8" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="58"/>
                <participants group_id="P6" count="54"/>
                <participants group_id="P7" count="51"/>
                <participants group_id="P8" count="55"/>
              </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="2"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</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="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</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 group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1, Group 1: HTX-011</title>
          <description>HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 1, Group 2: HTX-011</title>
          <description>HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).</description>
        </group>
        <group group_id="B3">
          <title>Cohort 1, Group 3: Saline Placebo</title>
          <description>Saline placebo via injection.</description>
        </group>
        <group group_id="B4">
          <title>Cohort 1, Group 4: Bupivacaine HCI</title>
          <description>Bupivacaine HCl without epinephrine, 125 mg via injection.</description>
        </group>
        <group group_id="B5">
          <title>Cohort 2, Group 1: HTX-011</title>
          <description>HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.</description>
        </group>
        <group group_id="B6">
          <title>Cohort 2, Group 2: HTX-011 + Ropivacaine</title>
          <description>HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.</description>
        </group>
        <group group_id="B7">
          <title>Cohort 2, Group 3: Saline Placebo</title>
          <description>Saline placebo via injection.</description>
        </group>
        <group group_id="B8">
          <title>Cohort 2, Group 4: Bupivacaine HCI</title>
          <description>Bupivacaine HCl without epinephrine, 125 mg via injection.</description>
        </group>
        <group group_id="B9">
          <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="20"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="11"/>
            <count group_id="B4" value="10"/>
            <count group_id="B5" value="58"/>
            <count group_id="B6" value="56"/>
            <count group_id="B7" value="53"/>
            <count group_id="B8" value="55"/>
            <count group_id="B9" value="285"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="31"/>
                    <measurement group_id="B6" value="34"/>
                    <measurement group_id="B7" value="36"/>
                    <measurement group_id="B8" value="38"/>
                    <measurement group_id="B9" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="27"/>
                    <measurement group_id="B6" value="22"/>
                    <measurement group_id="B7" value="17"/>
                    <measurement group_id="B8" value="17"/>
                    <measurement group_id="B9" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="62.1" spread="7.52"/>
                    <measurement group_id="B2" value="58.6" spread="7.44"/>
                    <measurement group_id="B3" value="64.9" spread="4.64"/>
                    <measurement group_id="B4" value="65.3" spread="11.62"/>
                    <measurement group_id="B5" value="62.5" spread="8.63"/>
                    <measurement group_id="B6" value="63.2" spread="9.36"/>
                    <measurement group_id="B7" value="61.5" spread="8.31"/>
                    <measurement group_id="B8" value="61.4" spread="9.37"/>
                    <measurement group_id="B9" value="62.1" spread="8.71"/>
                  </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="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="26"/>
                    <measurement group_id="B6" value="27"/>
                    <measurement group_id="B7" value="25"/>
                    <measurement group_id="B8" value="35"/>
                    <measurement group_id="B9" value="147"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="32"/>
                    <measurement group_id="B6" value="29"/>
                    <measurement group_id="B7" value="28"/>
                    <measurement group_id="B8" value="20"/>
                    <measurement group_id="B9" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="16"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="16"/>
                    <measurement group_id="B9" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="49"/>
                    <measurement group_id="B6" value="40"/>
                    <measurement group_id="B7" value="41"/>
                    <measurement group_id="B8" value="39"/>
                    <measurement group_id="B9" value="211"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="8"/>
                    <measurement group_id="B8" value="7"/>
                    <measurement group_id="B9" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="51"/>
                    <measurement group_id="B6" value="49"/>
                    <measurement group_id="B7" value="45"/>
                    <measurement group_id="B8" value="47"/>
                    <measurement group_id="B9" value="241"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="58"/>
                    <measurement group_id="B6" value="56"/>
                    <measurement group_id="B7" value="53"/>
                    <measurement group_id="B8" value="55"/>
                    <measurement group_id="B9" value="285"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores</title>
        <description>Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. NRS scores are recorded at rest (NRS-R).</description>
        <time_frame>48 hours</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, Group 1: HTX-011</title>
            <description>HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1, Group 2: HTX-011</title>
            <description>HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1, Group 3: Saline Placebo</title>
            <description>Saline placebo via injection.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1, Group 4: Bupivacaine HCI</title>
            <description>Bupivacaine HCl without epinephrine, 125 mg via injection.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2, Group 1: HTX-011</title>
            <description>HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 2, Group 2: HTX-011 + Ropivacaine</title>
            <description>HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 2, Group 3: Saline Placebo</title>
            <description>Saline placebo via injection.</description>
          </group>
          <group group_id="O8">
            <title>Cohort 2, Group 4: Bupivacaine HCI</title>
            <description>Bupivacaine HCl without epinephrine, 125 mg via injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores</title>
          <description>Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. NRS scores are recorded at rest (NRS-R).</description>
          <population>ITT Population</population>
          <units>pain intensity score*hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="58"/>
                <count group_id="O6" value="56"/>
                <count group_id="O7" value="53"/>
                <count group_id="O8" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="386.12" spread="82.930"/>
                    <measurement group_id="O2" value="391.56" spread="84.450"/>
                    <measurement group_id="O3" value="405.82" spread="97.549"/>
                    <measurement group_id="O4" value="347.56" spread="103.422"/>
                    <measurement group_id="O5" value="322.08" spread="99.669"/>
                    <measurement group_id="O6" value="307.25" spread="127.674"/>
                    <measurement group_id="O7" value="396.36" spread="77.468"/>
                    <measurement group_id="O8" value="352.74" spread="100.887"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores</title>
        <description>Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. NRS scores are recorded at rest (NRS-R).</description>
        <time_frame>72 hours</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, Group 1: HTX-011</title>
            <description>HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1, Group 2: HTX-011</title>
            <description>HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1, Group 3: Saline Placebo</title>
            <description>Saline placebo via injection.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1, Group 4: Bupivacaine HCI</title>
            <description>Bupivacaine HCl without epinephrine, 125 mg via injection.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2, Group 1: HTX-011</title>
            <description>HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 2, Group 2: HTX-011 + Ropivacaine</title>
            <description>HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 2, Group 3: Saline Placebo</title>
            <description>Saline placebo via injection.</description>
          </group>
          <group group_id="O8">
            <title>Cohort 2, Group 4: Bupivacaine HCI</title>
            <description>Bupivacaine HCl without epinephrine, 125 mg via injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores</title>
          <description>Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents &quot;no pain&quot; and 10 represents &quot;worst pain imaginable&quot;. NRS scores are recorded at rest (NRS-R).</description>
          <population>ITT Population</population>
          <units>pain intensity score*hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="58"/>
                <count group_id="O6" value="56"/>
                <count group_id="O7" value="53"/>
                <count group_id="O8" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="543.14" spread="142.566"/>
                    <measurement group_id="O2" value="560.85" spread="136.099"/>
                    <measurement group_id="O3" value="576.44" spread="150.815"/>
                    <measurement group_id="O4" value="468.58" spread="179.687"/>
                    <measurement group_id="O5" value="471.19" spread="149.443"/>
                    <measurement group_id="O6" value="452.54" spread="194.095"/>
                    <measurement group_id="O7" value="577.93" spread="125.102"/>
                    <measurement group_id="O8" value="516.93" spread="152.512"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)</title>
        <time_frame>72 hours</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, Group 1: HTX-011</title>
            <description>HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1, Group 2: HTX-011</title>
            <description>HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1, Group 3: Saline Placebo</title>
            <description>Saline placebo via injection.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1, Group 4: Bupivacaine HCI</title>
            <description>Bupivacaine HCl without epinephrine, 125 mg via injection.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2, Group 1: HTX-011</title>
            <description>HTX-011, 400 mg/12 mg via instillation.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 2, Group 2: HTX-011 + Ropivacaine</title>
            <description>HTX-011, 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 2, Group 3: Saline Placebo</title>
            <description>Saline placebo via injection.</description>
          </group>
          <group group_id="O8">
            <title>Cohort 2, Group 4: Bupivacaine HCI</title>
            <description>Bupivacaine HCl without epinephrine, 125 mg via injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)</title>
          <population>ITT Population</population>
          <units>morphine milligram equivalent (MME)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="58"/>
                <count group_id="O6" value="56"/>
                <count group_id="O7" value="53"/>
                <count group_id="O8" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.53" spread="31.615"/>
                    <measurement group_id="O2" value="66.86" spread="31.154"/>
                    <measurement group_id="O3" value="70.41" spread="18.057"/>
                    <measurement group_id="O4" value="60.70" spread="29.903"/>
                    <measurement group_id="O5" value="64.39" spread="27.889"/>
                    <measurement group_id="O6" value="60.32" spread="34.949"/>
                    <measurement group_id="O7" value="73.55" spread="34.448"/>
                    <measurement group_id="O8" value="68.35" spread="29.169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 Days.</time_frame>
      <desc>Subjects reporting more than one TEAE are counted only once.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1, Group 1: HTX-011</title>
          <description>HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 1, Group 2: HTX-011</title>
          <description>HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation(combination).</description>
        </group>
        <group group_id="E3">
          <title>Cohort 1, Group 3: Saline Placebo</title>
          <description>Saline placebo via injection.</description>
        </group>
        <group group_id="E4">
          <title>Cohort 1, Group 4: Bupivacaine HCI</title>
          <description>Bupivacaine HCl without epinephrine, 125 mg via injection.</description>
        </group>
        <group group_id="E5">
          <title>Cohort 2, Group 1: HTX-011</title>
          <description>HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.</description>
        </group>
        <group group_id="E6">
          <title>Cohort 2, Group 2: HTX-011 + Ropivacaine</title>
          <description>HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.</description>
        </group>
        <group group_id="E7">
          <title>Cohort 2, Group 3: Saline Placebo</title>
          <description>Saline placebo via injection.</description>
        </group>
        <group group_id="E8">
          <title>Cohort 2, Group 4: Bupivacaine HCI</title>
          <description>Bupivacaine HCl without epinephrine, 125 mg via injection.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="55"/>
              </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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Post procedural cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Respiratory depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</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="19" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="55" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="50" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="50" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="49" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="11" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="29" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="30" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="25" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="30" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="14" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="21" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="12" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="18" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="15" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="15" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Retching</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="8" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Medical device site reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Incision site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Postoperative fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Anaemia postoperative</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Incision site oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </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="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="9" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="9" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="8" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Laryngospasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Wound drainage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="55"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vice President, Clinical Operations</name_or_title>
      <organization>Heron Therapeutics, Inc.</organization>
      <phone>858-251-7232</phone>
      <email>svisonneau@herontx.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03015532
org study id: HTX-011-209
nct id: NCT03015532
lead sponsor: 
This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled,
      multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to
      evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered
      via infiltration to the surgical site.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores
time frame: 48 hours
description: Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded at rest (NRS-R).
measure: Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores
time frame: 72 hours
description: Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded at rest (NRS-R).
measure: Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)
time frame: 72 hours
arm group label: Cohort 1, Group 1: HTX-011
arm group type: Experimental
description: HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation
arm group label: Cohort 1, Group 2: HTX-011
arm group type: Experimental
description: HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination)
arm group label: Cohort 1, Group 3: Saline Placebo
arm group type: Placebo Comparator
description: Saline placebo via injection
arm group label: Cohort 1, Group 4: Bupivacaine HCI
arm group type: Active Comparator
description: Bupivacaine HCl without epinephrine, 125 mg via injection
arm group label: Cohort 2, Group 1: HTX-011
arm group type: Experimental
description: HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation
arm group label: Cohort 2, Group 2: HTX-011 + Ropivacaine
arm group type: Experimental
description: HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection
arm group label: Cohort 2, Group 3: Saline Placebo
arm group type: Placebo Comparator
description: Saline placebo via injection
arm group label: Cohort 2, Group 4: Bupivacaine HCI
arm group type: Active Comparator
description: Bupivacaine HCl without epinephrine, 125 mg via injection
intervention type: Drug
intervention name: HTX-011
description: HTX-011 (bupivacaine/meloxicam), via instillation
arm group label: Cohort 1, Group 1: HTX-011
arm group label: Cohort 1, Group 2: HTX-011
arm group label: Cohort 2, Group 1: HTX-011
arm group label: Cohort 2, Group 2: HTX-011 + Ropivacaine
intervention type: Drug
intervention name: Saline Placebo
description: Saline placebo via injection
arm group label: Cohort 1, Group 3: Saline Placebo
arm group label: Cohort 2, Group 3: Saline Placebo
intervention type: Drug
intervention name: Bupivicaine HCl
description: Bupivacaine HCl without epinephrine
arm group label: Cohort 1, Group 4: Bupivacaine HCI
arm group label: Cohort 2, Group 4: Bupivacaine HCI
intervention type: Drug
intervention name: Ropivacaine
description: Ropivacaine, via injection
arm group label: Cohort 2, Group 2: HTX-011 + Ropivacaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
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facility: 
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facility: 
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facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Bupivacaine
mesh term: Ropivacaine
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 