<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/NCT01728376</url>
  </required_header>
  <id_info>
    <org_study_id>3009-005</org_study_id>
    <secondary_id>DAP-PEDBAC-11-02</secondary_id>
    <nct_id>NCT01728376</nct_id>
  </id_info>
  <brief_title>Safety &amp; Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)</brief_title>
  <official_title>A Comparative Evaluation of the Safety and Efficacy of Daptomycin Versus Standard of Care in Pediatric Subjects One - Seventeen Years of Age With Bacteremia Caused by Staphylococcus Aureus.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cubist Pharmaceuticals LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cubist Pharmaceuticals LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The intent of this study is to describe the safety and efficacy of daptomycin versus standard&#xD;
      of care (SOC) in pediatric participants aged 1-17 years with bacteremia caused by&#xD;
      Staphylococcus aureus (S. aureus).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      S. aureus causes a series of invasive diseases in adults and children, including bacteremia.&#xD;
      Infections due to S. aureus in children, particularly those due to methicillin resistant S.&#xD;
      aureus (MRSA), are a growing world-wide public health concern.&#xD;
&#xD;
      Daptomycin, a cyclic lipopeptide antibacterial agent, shows rapid in vitro bactericidal&#xD;
      activity with concentration-dependent killing for Gram-positive organisms, including S.&#xD;
      aureus. Surveillance studies have demonstrated a daptomycin MIC90 of 0.5µg/ml for both&#xD;
      methicillin-susceptible S. aureus (MSSA) and MRSA with &gt;99% of MRSA isolates being&#xD;
      categorized as susceptible by the Food and Drug Administration (FDA), European Committee of&#xD;
      antimicrobial susceptibility testing (EUCAST) and Clinical and Laboratory Standards Institute&#xD;
      (CLSI) breakpoints (5). Clinical trials in adults demonstrated that daptomycin was safe and&#xD;
      efficacious in complicated skin and skin structure infections (cSSSI) and bloodstream&#xD;
      infections caused by S. aureus, including right-sided infective endocarditis (RIE). However,&#xD;
      information on the safety and efficacy of daptomycin for use in children is lacking.&#xD;
&#xD;
      The intent of this study in children is to confirm the safety of daptomycin at mean steady&#xD;
      state systemic exposures (AUC) similar to those reported for adults treated at 6 mg/kg for&#xD;
      bacteremia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2012</start_date>
  <completion_date type="Actual">January 20, 2016</completion_date>
  <primary_completion_date type="Actual">January 20, 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With One or More Adverse Events (AEs)</measure>
    <time_frame>Administration of first dose through the last follow-up visit (up to 77 days)</time_frame>
    <description>An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With One or More Serious Adverse Events (SAEs)</measure>
    <time_frame>Administration of first dose through the last follow-up visit (up to 77 days)</time_frame>
    <description>An SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death, life threatening experience, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is considered to be an important medical event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal</measure>
    <time_frame>Baseline up to end of therapy visit (up to 49 days)</time_frame>
    <description>Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with maximum post-baseline CPK elevations above the upper limit of 500 Units Per Liter (U/L) .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained CPK Elevations</measure>
    <time_frame>Baseline up to end of therapy visit (up to 44 days)</time_frame>
    <description>Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with sustained CPK elevations, defined as two consecutive post-baseline values above the upper limit of normal (ULN)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC)</measure>
    <time_frame>TOC Safety Visit (up to 56 days)</time_frame>
    <description>Focused neurological examinations were done at the TOC/Safety Visit. These examinations include assessments of sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose) and tremor of the hands/fingers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Clinical Success at TOC/Safety Visit</measure>
    <time_frame>7-14 days after the last dose of study medication (up to 56 days)</time_frame>
    <description>Clinical success was determined by assessing resolution/improvement of signs and symptoms. An assessment of cure or improved is considered clinical success. Cure: resolution of clinically significant signs and symptoms associated with admission infection; no further antibiotic therapy is required for the primary infection under study. Improvement: partial resolution of clinical signs/symptoms of infection such that no further antibiotic therapy is required for the primary infection under study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Overall Success at TOC Visit</measure>
    <time_frame>7-14 days after the last dose of study medication (up to 56 days)</time_frame>
    <description>Overall success is based on microbiologic responses after initiating study drug and clinical response at TOC/Safety Visit. Overall outcome is a success if both clinical and microbiologic outcomes are successes. An assessment of cure or improved is considered clinical success. Microbiological Success: a participant for whom all baseline infecting pathogens were eradicated (presumed or documented) within 7 days from the start of study drug for uncomplicated bacteremia with no source of infection present, and 10 days for complicated bacteremia or when the source of infection has not been removed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough Plasma Concentration of Daptomycin</measure>
    <time_frame>Days 3, 4, 5 or 6 of treatment at pre-dose</time_frame>
    <description>Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Trough concentrations were collected 22 to 26 hours following the end of the previous day's end of infusion and before the next infusion. Concentrations below the limit of quantification were excluded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) of Daptomycin</measure>
    <time_frame>Days 3, 4, 5 or 6 of treatment at end of infusion</time_frame>
    <description>Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Peak concentrations were collected up to 15 minutes following the end of infusion. Concentrations below the limit of quantification were excluded.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Bacteremia</condition>
  <arm_group>
    <arm_group_label>Daptomycin - 12 to 17 year olds</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously (IV), over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator - 12 to 17 year olds</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Daptomycin - 7 to 11 year olds</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants ages 7 to 11 years old were administered daptomycin 9 mg/kg, infused once daily, IV over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Daptomycin - 1 to 6 year olds</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, IV over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator - 7 to 11 year olds</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants ages 7-11 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator - 1 to 6 year olds</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daptomycin</intervention_name>
    <description>Intravenous daptomycin given at 7 mg/kg (ages 12-17 years); 9 mg/kg (ages 7-11 years); 12 mg/kg (ages 1-6 years) infused once daily, intravenously, over 30 or 60 minutes. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.</description>
    <arm_group_label>Daptomycin - 1 to 6 year olds</arm_group_label>
    <arm_group_label>Daptomycin - 12 to 17 year olds</arm_group_label>
    <arm_group_label>Daptomycin - 7 to 11 year olds</arm_group_label>
    <other_name>Cubicin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Comparator</intervention_name>
    <description>Vancomycin, Semi-synthetic penicillin, First-generation cephalosporins, Clindamycin: administered per standard of care. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.</description>
    <arm_group_label>Comparator - 1 to 6 year olds</arm_group_label>
    <arm_group_label>Comparator - 12 to 17 year olds</arm_group_label>
    <arm_group_label>Comparator - 7 to 11 year olds</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be included in this study, participants must:&#xD;
&#xD;
          -  Sign a parental consent form; if appropriate, sign an assent form&#xD;
&#xD;
          -  Be between 1 and 17 years of age&#xD;
&#xD;
          -  Have proven or probable bacteremia caused by S. aureus based on the traditional&#xD;
             culture result, rapid diagnostic test or Gram stain&#xD;
&#xD;
          -  If female of childbearing potential, must not be pregnant or nursing and take&#xD;
             appropriate measures to not get pregnant during the study&#xD;
&#xD;
          -  If male, must take appropriate measures to not get partner pregnant&#xD;
&#xD;
          -  Able to comply with the protocol requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants will not be allowed into the study if they:&#xD;
&#xD;
          -  Have received a certain amount of antibacterial therapy specific for current&#xD;
             bacteremia unless it is demonstrated that the organism is resistant to the given&#xD;
             antibacterial;&#xD;
&#xD;
          -  Anticipate to require other antibiotics that may be potentially effective against S.&#xD;
             aureus;&#xD;
&#xD;
          -  Have shock or hypotension unresponsive to standard therapy;&#xD;
&#xD;
          -  Have received an investigational product or have participated in an experimental&#xD;
             procedure within 30 days;&#xD;
&#xD;
          -  Have an intolerance or hypersensitivity to daptomycin;&#xD;
&#xD;
          -  Have renal insufficiency;&#xD;
&#xD;
          -  Have prior history or current evidence of muscle damage (rhabdomyolysis; significant&#xD;
             CPK elevation);&#xD;
&#xD;
          -  Have history of clinically significant muscular disease, nervous system or seizure&#xD;
             disorder, including unexplained muscular weakness, history of peripheral neuropathy,&#xD;
             Guillain-Barré or spinal cord injury;&#xD;
&#xD;
          -  Have S. aureus pneumonia, empyema, meningitis, or endocarditis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Greece</country>
    <country>Guatemala</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Malaysia</country>
    <country>Panama</country>
    <country>Romania</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Ukraine</country>
    <country>United States</country>
  </removed_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <results_first_submitted>October 13, 2016</results_first_submitted>
  <results_first_submitted_qc>October 13, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 7, 2016</results_first_posted>
  <last_update_submitted>July 31, 2018</last_update_submitted>
  <last_update_submitted_qc>July 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacteremia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Daptomycin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants aged 1-17 with bacteremia caused by Staphylococcus aureus (S. aureus) were enrolled in this study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Daptomycin - 1 to 6 Year Olds</title>
          <description>Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
        </group>
        <group group_id="P2">
          <title>Comparator- 1 to 6 Year Olds</title>
          <description>Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
        </group>
        <group group_id="P3">
          <title>Daptomycin - 7 to 11 Year Olds</title>
          <description>Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
        </group>
        <group group_id="P4">
          <title>Comparator - 7 to 11 Year Olds</title>
          <description>Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
        </group>
        <group group_id="P5">
          <title>Daptomycin - 12 to 17 Year Olds</title>
          <description>Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
        </group>
        <group group_id="P6">
          <title>Comparator - 12 to 17 Year Olds</title>
          <description>Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="14"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="14"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Persistent Positive Blood Cultures</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No relevant bacteria</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not receive treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject/Parent/Legal Guardian Decision</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="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants who received any dose of IV study medication.</population>
      <group_list>
        <group group_id="B1">
          <title>Daptomycin - 1 to 6 Year Olds</title>
          <description>Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
        </group>
        <group group_id="B2">
          <title>Comparator- 1 to 6 Year Olds</title>
          <description>Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
        </group>
        <group group_id="B3">
          <title>Daptomycin - 7 to 11 Year Olds</title>
          <description>Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
        </group>
        <group group_id="B4">
          <title>Comparator - 7 to 11 Year Olds</title>
          <description>Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
        </group>
        <group group_id="B5">
          <title>Daptomycin - 12 to 17 Year Olds</title>
          <description>Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
        </group>
        <group group_id="B6">
          <title>Comparator - 12 to 17 Year Olds</title>
          <description>Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
        </group>
        <group group_id="B7">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="19"/>
            <count group_id="B4" value="9"/>
            <count group_id="B5" value="14"/>
            <count group_id="B6" value="7"/>
            <count group_id="B7" value="81"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.81" spread="1.232"/>
                    <measurement group_id="B2" value="4.13" spread="1.752"/>
                    <measurement group_id="B3" value="10.25" spread="1.217"/>
                    <measurement group_id="B4" value="9.46" spread="1.345"/>
                    <measurement group_id="B5" value="14.14" spread="1.677"/>
                    <measurement group_id="B6" value="14.56" spread="1.868"/>
                    <measurement group_id="B7" value="8.70" spread="4.468"/>
                  </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="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="14"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With One or More Adverse Events (AEs)</title>
        <description>An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.</description>
        <time_frame>Administration of first dose through the last follow-up visit (up to 77 days)</time_frame>
        <population>Participants who received any dose of IV study medication</population>
        <group_list>
          <group group_id="O1">
            <title>Daptomycin - 1 to 6 Year Olds</title>
            <description>Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O2">
            <title>Comparator- 1 to 6 Year Olds</title>
            <description>Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O3">
            <title>Daptomycin - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O4">
            <title>Comparator - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O5">
            <title>Daptomycin - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O6">
            <title>Comparator - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With One or More Adverse Events (AEs)</title>
          <description>An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.</description>
          <population>Participants who received any dose of IV study medication</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="14"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With One or More Serious Adverse Events (SAEs)</title>
        <description>An SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death, life threatening experience, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is considered to be an important medical event.</description>
        <time_frame>Administration of first dose through the last follow-up visit (up to 77 days)</time_frame>
        <population>Participants who received any dose of IV study medication</population>
        <group_list>
          <group group_id="O1">
            <title>Daptomycin - 1 to 6 Year Olds</title>
            <description>Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O2">
            <title>Comparator- 1 to 6 Year Olds</title>
            <description>Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O3">
            <title>Daptomycin - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O4">
            <title>Comparator - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O5">
            <title>Daptomycin - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O6">
            <title>Comparator - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With One or More Serious Adverse Events (SAEs)</title>
          <description>An SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death, life threatening experience, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is considered to be an important medical event.</description>
          <population>Participants who received any dose of IV study medication</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="14"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal</title>
        <description>Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with maximum post-baseline CPK elevations above the upper limit of 500 Units Per Liter (U/L) .</description>
        <time_frame>Baseline up to end of therapy visit (up to 49 days)</time_frame>
        <population>Participants who received any dose of IV study medication</population>
        <group_list>
          <group group_id="O1">
            <title>Daptomycin - 1 to 6 Year Olds</title>
            <description>Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O2">
            <title>Comparator- 1 to 6 Year Olds</title>
            <description>Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O3">
            <title>Daptomycin - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O4">
            <title>Comparator - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O5">
            <title>Daptomycin - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O6">
            <title>Comparator - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal</title>
          <description>Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with maximum post-baseline CPK elevations above the upper limit of 500 Units Per Liter (U/L) .</description>
          <population>Participants who received any dose of IV study medication</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="14"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.9"/>
                    <measurement group_id="O2" value="40.0"/>
                    <measurement group_id="O3" value="10.5"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="28.6"/>
                    <measurement group_id="O6" value="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Sustained CPK Elevations</title>
        <description>Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with sustained CPK elevations, defined as two consecutive post-baseline values above the upper limit of normal (ULN)</description>
        <time_frame>Baseline up to end of therapy visit (up to 44 days)</time_frame>
        <population>Participants who received any dose of IV study medication</population>
        <group_list>
          <group group_id="O1">
            <title>Daptomycin - 1 to 6 Year Olds</title>
            <description>Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O2">
            <title>Comparator- 1 to 6 Year Olds</title>
            <description>Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O3">
            <title>Daptomycin - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O4">
            <title>Comparator - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O5">
            <title>Daptomycin - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O6">
            <title>Comparator - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained CPK Elevations</title>
          <description>Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with sustained CPK elevations, defined as two consecutive post-baseline values above the upper limit of normal (ULN)</description>
          <population>Participants who received any dose of IV study medication</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="14"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2"/>
                    <measurement group_id="O2" value="20.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="28.6"/>
                    <measurement group_id="O6" value="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC)</title>
        <description>Focused neurological examinations were done at the TOC/Safety Visit. These examinations include assessments of sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose) and tremor of the hands/fingers.</description>
        <time_frame>TOC Safety Visit (up to 56 days)</time_frame>
        <population>Participants who received any dose of IV study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Daptomycin - 1 to 6 Year Olds</title>
            <description>Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O2">
            <title>Comparator- 1 to 6 Year Olds</title>
            <description>Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O3">
            <title>Daptomycin - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O4">
            <title>Comparator - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O5">
            <title>Daptomycin - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O6">
            <title>Comparator - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC)</title>
          <description>Focused neurological examinations were done at the TOC/Safety Visit. These examinations include assessments of sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose) and tremor of the hands/fingers.</description>
          <population>Participants who received any dose of IV study medication.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="14"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alertness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pupillary Reflex and Tracking</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peripheral Reflex - Biceps</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peripheral Reflex - Patellar Tendon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peripheral Reflex - Ankle Jerk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peripheral Reflex - Plantar Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle Tone - Lower/Upper Limbs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle Strength - Lower/Upper Limbs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coordination - (Finger to Nose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tremor of the hands/fingers</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Clinical Success at TOC/Safety Visit</title>
        <description>Clinical success was determined by assessing resolution/improvement of signs and symptoms. An assessment of cure or improved is considered clinical success. Cure: resolution of clinically significant signs and symptoms associated with admission infection; no further antibiotic therapy is required for the primary infection under study. Improvement: partial resolution of clinical signs/symptoms of infection such that no further antibiotic therapy is required for the primary infection under study.</description>
        <time_frame>7-14 days after the last dose of study medication (up to 56 days)</time_frame>
        <population>All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Daptomycin - 1 to 6 Year Olds</title>
            <description>Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O2">
            <title>Comparator- 1 to 6 Year Olds</title>
            <description>Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O3">
            <title>Daptomycin - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O4">
            <title>Comparator - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O5">
            <title>Daptomycin - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O6">
            <title>Comparator - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Success at TOC/Safety Visit</title>
          <description>Clinical success was determined by assessing resolution/improvement of signs and symptoms. An assessment of cure or improved is considered clinical success. Cure: resolution of clinically significant signs and symptoms associated with admission infection; no further antibiotic therapy is required for the primary infection under study. Improvement: partial resolution of clinical signs/symptoms of infection such that no further antibiotic therapy is required for the primary infection under study.</description>
          <population>All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="14"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cured</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.0"/>
                    <measurement group_id="O2" value="87.5"/>
                    <measurement group_id="O3" value="94.1"/>
                    <measurement group_id="O4" value="77.8"/>
                    <measurement group_id="O5" value="78.6"/>
                    <measurement group_id="O6" value="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="7.1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference (%)</param_type>
            <param_value>-2.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.3</ci_lower_limit>
            <ci_upper_limit>25.3</ci_upper_limit>
            <estimate_desc>Daptomycin minus Comparator 95% Confidence Interval (CI) by Wilson score method</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference (%)</param_type>
            <param_value>16.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.0</ci_lower_limit>
            <ci_upper_limit>45.7</ci_upper_limit>
            <estimate_desc>Daptomycin minus Comparator 95% CI by Wilson score method</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference (%)</param_type>
            <param_value>25.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.0</ci_lower_limit>
            <ci_upper_limit>72.4</ci_upper_limit>
            <estimate_desc>Daptomycin minus Comparator 95% CI by Wilson score method</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Overall Success at TOC Visit</title>
        <description>Overall success is based on microbiologic responses after initiating study drug and clinical response at TOC/Safety Visit. Overall outcome is a success if both clinical and microbiologic outcomes are successes. An assessment of cure or improved is considered clinical success. Microbiological Success: a participant for whom all baseline infecting pathogens were eradicated (presumed or documented) within 7 days from the start of study drug for uncomplicated bacteremia with no source of infection present, and 10 days for complicated bacteremia or when the source of infection has not been removed.</description>
        <time_frame>7-14 days after the last dose of study medication (up to 56 days)</time_frame>
        <population>All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Daptomycin - 1 to 6 Year Olds</title>
            <description>Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O2">
            <title>Comparator- 1 to 6 Year Olds</title>
            <description>Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O3">
            <title>Daptomycin - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O4">
            <title>Comparator - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O5">
            <title>Daptomycin - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O6">
            <title>Comparator - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Overall Success at TOC Visit</title>
          <description>Overall success is based on microbiologic responses after initiating study drug and clinical response at TOC/Safety Visit. Overall outcome is a success if both clinical and microbiologic outcomes are successes. An assessment of cure or improved is considered clinical success. Microbiological Success: a participant for whom all baseline infecting pathogens were eradicated (presumed or documented) within 7 days from the start of study drug for uncomplicated bacteremia with no source of infection present, and 10 days for complicated bacteremia or when the source of infection has not been removed.</description>
          <population>All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="14"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.0"/>
                    <measurement group_id="O2" value="75.0"/>
                    <measurement group_id="O3" value="82.4"/>
                    <measurement group_id="O4" value="44.4"/>
                    <measurement group_id="O5" value="50.0"/>
                    <measurement group_id="O6" value="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference in success response between treatment arms</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference (%)</param_type>
            <param_value>5.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-29.8</ci_lower_limit>
            <ci_upper_limit>39.8</ci_upper_limit>
            <estimate_desc>Daptomycin minus Comparator 95% CI by Wilson score method</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference in success response between treatment arms</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference (%)</param_type>
            <param_value>37.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7</ci_lower_limit>
            <ci_upper_limit>75.1</ci_upper_limit>
            <estimate_desc>Daptomycin minus Comparator 95% CI by Wilson score method</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Difference in success response between treatment arms</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference (%)</param_type>
            <param_value>-10.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-60.3</ci_lower_limit>
            <ci_upper_limit>40.3</ci_upper_limit>
            <estimate_desc>Daptomycin minus Comparator 95% CI by Wilson score method</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Trough Plasma Concentration of Daptomycin</title>
        <description>Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Trough concentrations were collected 22 to 26 hours following the end of the previous day's end of infusion and before the next infusion. Concentrations below the limit of quantification were excluded.</description>
        <time_frame>Days 3, 4, 5 or 6 of treatment at pre-dose</time_frame>
        <population>Participants treated with daptomycin with at least one trough sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.</population>
        <group_list>
          <group group_id="O1">
            <title>Daptomycin - 1 to 6 Year Olds</title>
            <description>Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O2">
            <title>Comparator- 1 to 6 Year Olds</title>
            <description>Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O3">
            <title>Daptomycin - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O4">
            <title>Comparator - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O5">
            <title>Daptomycin - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O6">
            <title>Comparator - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Trough Plasma Concentration of Daptomycin</title>
          <description>Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Trough concentrations were collected 22 to 26 hours following the end of the previous day's end of infusion and before the next infusion. Concentrations below the limit of quantification were excluded.</description>
          <population>Participants treated with daptomycin with at least one trough sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.72" spread="1.643"/>
                    <measurement group_id="O3" value="6.39" spread="3.035"/>
                    <measurement group_id="O5" value="14.69" spread="19.109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Plasma Concentration (Cmax) of Daptomycin</title>
        <description>Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Peak concentrations were collected up to 15 minutes following the end of infusion. Concentrations below the limit of quantification were excluded.</description>
        <time_frame>Days 3, 4, 5 or 6 of treatment at end of infusion</time_frame>
        <population>Participants treated with daptomycin with at least one peak sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.</population>
        <group_list>
          <group group_id="O1">
            <title>Daptomycin - 1 to 6 Year Olds</title>
            <description>Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O2">
            <title>Comparator- 1 to 6 Year Olds</title>
            <description>Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O3">
            <title>Daptomycin - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O4">
            <title>Comparator - 7 to 11 Year Olds</title>
            <description>Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
          <group group_id="O5">
            <title>Daptomycin - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
          </group>
          <group group_id="O6">
            <title>Comparator - 12 to 17 Year Olds</title>
            <description>Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Plasma Concentration (Cmax) of Daptomycin</title>
          <description>Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Peak concentrations were collected up to 15 minutes following the end of infusion. Concentrations below the limit of quantification were excluded.</description>
          <population>Participants treated with daptomycin with at least one peak sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.69" spread="32.946"/>
                    <measurement group_id="O3" value="87.66" spread="34.992"/>
                    <measurement group_id="O5" value="74.70" spread="34.909"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Administration of first dose through the last follow-up visit (up to 77 days).</time_frame>
      <desc>Participants who received any dose of IV study medication</desc>
      <group_list>
        <group group_id="E1">
          <title>Daptomycin - 1 to 6 Year Olds</title>
          <description>Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
        </group>
        <group group_id="E2">
          <title>Comparator - 1 to 6 Year Olds</title>
          <description>Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
        </group>
        <group group_id="E3">
          <title>Daptomycin - 7 to 11 Year Olds</title>
          <description>Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
        </group>
        <group group_id="E4">
          <title>Comparator - 7 to 11 Year Olds</title>
          <description>Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
        </group>
        <group group_id="E5">
          <title>Daptomycin - 12 to 17 Year Olds</title>
          <description>Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).</description>
        </group>
        <group group_id="E6">
          <title>Comparator - 12 to 17 Year Olds</title>
          <description>Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Device breakage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Intestine transplant rejection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Bone abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Muscle abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Synovitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.1</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="9" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="14"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal lymphadenopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site discharge</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Catheter site oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Device breakage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Infusion site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Infected skin ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lung abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Osteomyelitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rash pustular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rhinovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Systemic candida</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Varicella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title vocab="MedDRA Version 17.1">Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Blood sodium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title vocab="MedDRA Version 17.1">Body temperature increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hyperphosphataemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Haemarthrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal behaviour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Renal necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Epididymal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pharyngeal ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </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>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.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/NCT01728376
org study id: 3009-005
secondary id: DAP-PEDBAC-11-02
nct id: NCT01728376
lead sponsor: 
has dmc: Yes
The intent of this study is to describe the safety and efficacy of daptomycin versus standard
      of care (SOC) in pediatric participants aged 1-17 years with bacteremia caused by
      Staphylococcus aureus (S. aureus).
S. aureus causes a series of invasive diseases in adults and children, including bacteremia.
      Infections due to S. aureus in children, particularly those due to methicillin resistant S.
      aureus (MRSA), are a growing world-wide public health concern.

      Daptomycin, a cyclic lipopeptide antibacterial agent, shows rapid in vitro bactericidal
      activity with concentration-dependent killing for Gram-positive organisms, including S.
      aureus. Surveillance studies have demonstrated a daptomycin MIC90 of 0.5µg/ml for both
      methicillin-susceptible S. aureus (MSSA) and MRSA with >99% of MRSA isolates being
      categorized as susceptible by the Food and Drug Administration (FDA), European Committee of
      antimicrobial susceptibility testing (EUCAST) and Clinical and Laboratory Standards Institute
      (CLSI) breakpoints (5). Clinical trials in adults demonstrated that daptomycin was safe and
      efficacious in complicated skin and skin structure infections (cSSSI) and bloodstream
      infections caused by S. aureus, including right-sided infective endocarditis (RIE). However,
      information on the safety and efficacy of daptomycin for use in children is lacking.

      The intent of this study in children is to confirm the safety of daptomycin at mean steady
      state systemic exposures (AUC) similar to those reported for adults treated at 6 mg/kg for
      bacteremia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With One or More Adverse Events (AEs)
time frame: Administration of first dose through the last follow-up visit (up to 77 days)
description: An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
measure: Number of Participants With One or More Serious Adverse Events (SAEs)
time frame: Administration of first dose through the last follow-up visit (up to 77 days)
description: An SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death, life threatening experience, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is considered to be an important medical event.
measure: Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal
time frame: Baseline up to end of therapy visit (up to 49 days)
description: Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with maximum post-baseline CPK elevations above the upper limit of 500 Units Per Liter (U/L) .
measure: Percentage of Participants With Sustained CPK Elevations
time frame: Baseline up to end of therapy visit (up to 44 days)
description: Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with sustained CPK elevations, defined as two consecutive post-baseline values above the upper limit of normal (ULN)
measure: Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC)
time frame: TOC Safety Visit (up to 56 days)
description: Focused neurological examinations were done at the TOC/Safety Visit. These examinations include assessments of sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose) and tremor of the hands/fingers.
measure: Percentage of Participants With Clinical Success at TOC/Safety Visit
time frame: 7-14 days after the last dose of study medication (up to 56 days)
description: Clinical success was determined by assessing resolution/improvement of signs and symptoms. An assessment of cure or improved is considered clinical success. Cure: resolution of clinically significant signs and symptoms associated with admission infection; no further antibiotic therapy is required for the primary infection under study. Improvement: partial resolution of clinical signs/symptoms of infection such that no further antibiotic therapy is required for the primary infection under study.
measure: Percentage of Participants With Overall Success at TOC Visit
time frame: 7-14 days after the last dose of study medication (up to 56 days)
description: Overall success is based on microbiologic responses after initiating study drug and clinical response at TOC/Safety Visit. Overall outcome is a success if both clinical and microbiologic outcomes are successes. An assessment of cure or improved is considered clinical success. Microbiological Success: a participant for whom all baseline infecting pathogens were eradicated (presumed or documented) within 7 days from the start of study drug for uncomplicated bacteremia with no source of infection present, and 10 days for complicated bacteremia or when the source of infection has not been removed.
measure: Trough Plasma Concentration of Daptomycin
time frame: Days 3, 4, 5 or 6 of treatment at pre-dose
description: Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Trough concentrations were collected 22 to 26 hours following the end of the previous day's end of infusion and before the next infusion. Concentrations below the limit of quantification were excluded.
measure: Maximum Plasma Concentration (Cmax) of Daptomycin
time frame: Days 3, 4, 5 or 6 of treatment at end of infusion
description: Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Peak concentrations were collected up to 15 minutes following the end of infusion. Concentrations below the limit of quantification were excluded.
arm group label: Daptomycin - 12 to 17 year olds
arm group type: Experimental
description: Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously (IV), over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
arm group label: Comparator - 12 to 17 year olds
arm group type: Active Comparator
description: Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
arm group label: Daptomycin - 7 to 11 year olds
arm group type: Experimental
description: Participants ages 7 to 11 years old were administered daptomycin 9 mg/kg, infused once daily, IV over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
arm group label: Daptomycin - 1 to 6 year olds
arm group type: Experimental
description: Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, IV over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
arm group label: Comparator - 7 to 11 year olds
arm group type: Active Comparator
description: Participants ages 7-11 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
arm group label: Comparator - 1 to 6 year olds
arm group type: Active Comparator
description: Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
intervention type: Drug
intervention name: Daptomycin
description: Intravenous daptomycin given at 7 mg/kg (ages 12-17 years); 9 mg/kg (ages 7-11 years); 12 mg/kg (ages 1-6 years) infused once daily, intravenously, over 30 or 60 minutes. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.
arm group label: Daptomycin - 1 to 6 year olds
arm group label: Daptomycin - 12 to 17 year olds
arm group label: Daptomycin - 7 to 11 year olds
other name: Cubicin
intervention type: Drug
intervention name: Comparator
description: Vancomycin, Semi-synthetic penicillin, First-generation cephalosporins, Clindamycin: administered per standard of care. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.
arm group label: Comparator - 1 to 6 year olds
arm group label: Comparator - 12 to 17 year olds
arm group label: Comparator - 7 to 11 year olds
criteria: 
gender: All
minimum age: 1 Year
maximum age: 17 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Argentina
country: Australia
country: Brazil
country: Chile
country: Colombia
country: Greece
country: Guatemala
country: Hungary
country: Israel
country: Italy
country: Malaysia
country: Panama
country: Romania
country: Spain
country: Taiwan
country: Thailand
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Bacteremia
mesh term: Daptomycin
sharing ipd: Yes
ipd description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 