<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/NCT01702571</url>
  </required_header>
  <id_info>
    <org_study_id>MO28231</org_study_id>
    <secondary_id>2012-001628-37</secondary_id>
    <nct_id>NCT01702571</nct_id>
  </id_info>
  <brief_title>A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment</brief_title>
  <official_title>A Two-Cohort, Open-Label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-Based Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This two-cohort, open-label, multicenter study will assess the safety, efficacy and&#xD;
      tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced&#xD;
      breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and&#xD;
      chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general&#xD;
      participant population; Cohort 2 will include only Asian participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2012</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Adverse Events of Primary Interest (AEPIs)</measure>
    <time_frame>Baseline up to approximately 7 years</time_frame>
    <description>The AEPIs in this study were defined as the following: adverse events (AEs) Grade &gt;/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade &gt;/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Specific AEPIs</measure>
    <time_frame>Baseline up to approximately 7 years</time_frame>
    <description>The AEPIs in this study were defined as the following: adverse events (AEs) Grade &gt;/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade &gt;/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Events of Special Interest (AESIs)</measure>
    <time_frame>Baseline up to approximately 7 years</time_frame>
    <description>AESIs included: 1) Potential drug-induced liver injury, which included any potential case of drug-induced liver injury as, assessed by laboratory criteria for Hy's law (AST and/or ALT elevations that were &gt;3 × ULN, Concurrent elevation of total bilirubin &gt;2 × ULN (or clinical jaundice if total bilirubin measures were not available), except in participants with documented Gilbert's syndrome. Those with Gilbert's syndrome, elevation of direct bilirubin &gt;2 × ULN was used instead. 2) Suspected transmission of an infectious agent by study drug was defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic. A transmission of an infectious agent suspected from clinical symptoms or laboratory findings indicating an infection in a participant exposed to a medicinal product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment</measure>
    <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)</time_frame>
    <description>Progression free survival is defined as the time (in months) between the date of first dose and the date of disease progression or death from any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of &gt;/= 5 millimeters (mm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Baseline until death (up to approximately 7 years)</time_frame>
    <description>Overall survival is defined as time to death, which is the time from the date of dosing until the date of death, regardless of the cause of death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment</measure>
    <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)</time_frame>
    <description>Best Overall Response reported here is the Best confirmed Overall Response. To be assigned a status of PR or CR, i.e., to be a responder, changes in tumor measurements had to be confirmed by repeat assessments that had to be performed no less than 4 weeks after the criteria for response were first met, i.e., participants needed to have two consecutive assessments of PR or CR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1</measure>
    <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)</time_frame>
    <description>Clinical Benefit was defined as CR plus PR plus SD. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) According to RECIST v 1.1</measure>
    <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)</time_frame>
    <description>DOR is defined as the period from the date of initial confirmed PR or CR (whichever occurs first) until the date of PD or death from any cause. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of &gt;/= 5 millimeters (mm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response According to RECIST v 1.1</measure>
    <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)</time_frame>
    <description>Time to Response is defined as the time from first dose to first documentation of confirmed PR or CR (whichever occurs first). CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hospital Visits</measure>
    <time_frame>Baseline up to approximately 7 years</time_frame>
    <description>The number of hospital visits were recorded to evaluate the resoruce expenditures while participants were on study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of Hospital Visits</measure>
    <time_frame>Baseline up to approximately 7 years</time_frame>
    <description>The type of hospital visits (intensive care unit (ICU) versus other) were recorded to evaluate the resoruce expenditures while participants were on study treatment. The number of participants with at least one ICU visit are based on the number of participants with at least one hospital visit, in each group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2185</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Trastuzumab Emtansine (All Participants)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This cohort will enroll all participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trastuzumab Emtansine (Asian Participants)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This cohort will enroll Asian race participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trastuzumab Emtansine</intervention_name>
    <description>Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenously on Day 1 of a 3-week cycle every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
    <arm_group_label>Trastuzumab Emtansine (All Participants)</arm_group_label>
    <arm_group_label>Trastuzumab Emtansine (Asian Participants)</arm_group_label>
    <other_name>RO5304020, T-DM1, Kadcyla</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HER2-positive disease determined locally&#xD;
&#xD;
          -  Histologically or cytologically confirmed invasive breast cancer&#xD;
&#xD;
          -  Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or&#xD;
             metastatic setting must include both chemotherapy, alone or in combination with&#xD;
             another agent, and an anti-HER2 agent, alone or in combination with another agent&#xD;
&#xD;
          -  Documented progression of incurable, unresectable, LABC, or mBC, defined by the&#xD;
             investigator: progression must occur during or after most recent treatment for&#xD;
             LABC/mBC or within 6 months of completing adjuvant therapy&#xD;
&#xD;
          -  Measurable and/or non-measurable disease&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) &gt;/=50% by either echocardiogram (ECHO) or&#xD;
             multiple-gated acquisition scan (MUGA)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
          -  Use of highly effective contraception as defined by the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of treatment with trastuzumab emtansine&#xD;
&#xD;
          -  Prior enrollment into a clinical study containing trastuzumab emtansine regardless of&#xD;
             having received trastuzumab emtansine or not&#xD;
&#xD;
          -  Peripheral neuropathy of Grade &gt;/= 3 per National Cancer Institute (NCI) common&#xD;
             terminology criteria for adverse events (CTCAE) v 4.0&#xD;
&#xD;
          -  History of other malignancy within the previous 5 years, except for appropriately&#xD;
             treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine&#xD;
             cancer, synchronous or previously diagnosed HER2-positive breast cancer&#xD;
&#xD;
          -  History of receiving any anti-cancer drug/biologic or investigational treatment within&#xD;
             21 days prior to first study treatment except hormone therapy, which can be given up&#xD;
             to 7 days prior to first study treatment; recovery of treatment-related toxicity&#xD;
             consistent with other eligibility criteria&#xD;
&#xD;
          -  History of exposure to cumulative doses of anthracyclines&#xD;
&#xD;
          -  History of radiation therapy within 14 days of first study treatment. The participant&#xD;
             must have recovered from any resulting acute toxicity (to Grade &lt;/=1) prior to first&#xD;
             study treatment.&#xD;
&#xD;
          -  Metastatic central nervous system (CNS) disease only&#xD;
&#xD;
          -  Brain metastases which are symptomatic&#xD;
&#xD;
          -  History of a decrease in LVEF to less than (&lt;) 40% or symptomatic congestive heart&#xD;
             failure (CHF) with previous trastuzumab treatment&#xD;
&#xD;
          -  History of symptomatic CHF (New York Heart Association [NYHA] Classes II-IV) or&#xD;
             serious cardiac arrhythmia requiring treatment&#xD;
&#xD;
          -  History of myocardial infarction or unstable angina within 6 months of first study&#xD;
             treatment&#xD;
&#xD;
          -  Current dyspnea at rest due to complications of advanced malignancy or requirement for&#xD;
             continuous oxygen therapy&#xD;
&#xD;
          -  Current severe, uncontrolled systemic disease (clinically significant cardiovascular,&#xD;
             pulmonary, or metabolic disease)&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Currently known active infection with human immunodeficiency virus (HIV), hepatitis B&#xD;
             virus, or hepatitis C virus&#xD;
&#xD;
          -  History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to&#xD;
             trastuzumab or murine proteins or any component of the product&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CEMIC</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1431FWO</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Oncologico Riojano Integral (CORI)</name>
      <address>
        <city>La Rioja</city>
        <zip>F5300COE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Privado De Comunidad; General Practice</name>
      <address>
        <city>Mar Del Plata</city>
        <zip>7600</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research</name>
      <address>
        <city>North Sydney</city>
        <state>New South Wales</state>
        <zip>2059</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calvary Mater Newcastle; Medical Oncology</name>
      <address>
        <city>Waratah</city>
        <state>New South Wales</state>
        <zip>2298</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital; Medical Oncology and Pallative Care</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haematology &amp; Oncology Clinics of Australia Research Centre</name>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ashford Cancer Center Research</name>
      <address>
        <city>Kurralta Park</city>
        <state>South Australia</state>
        <zip>5037</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Centre; Medical Oncology</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunshine Hospital; Oncology Research</name>
      <address>
        <city>St Albans</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fiona Stanley Hospital</name>
      <address>
        <city>Murdoch</city>
        <state>Western Australia</state>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Anderlecht</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Brussel</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires St-Luc</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GHdC Site Notre Dame</name>
      <address>
        <city>Charleroi</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Antwerpen</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Sart-Tilman</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Ste-Elisabeth</name>
      <address>
        <city>Namur</city>
        <zip>5000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sint Augustinus Wilrijk, Apotheek</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>*X*Instituto Nacional do Cancer - INCA</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>20560-120</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sao Lucas - PUCRS</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Pesquisas Oncologicas - CEPON</name>
      <address>
        <city>Florianopolis</city>
        <state>SC</state>
        <zip>88034-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sirio Libanes; Centro de Oncologia</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01308-050</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sao Jose</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01321-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Serdika; Department of medical oncology</name>
      <address>
        <city>Sofia</city>
        <zip>1303</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SHATO - Sofia</name>
      <address>
        <city>Sofia</city>
        <zip>1756</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SHATOD - Sofia</name>
      <address>
        <city>Sofia</city>
        <zip>1784</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>District Oncology Dispensary Wit Stationary</name>
      <address>
        <city>Varna</city>
        <zip>9010</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BC Cancer - Surrey</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3V 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. H. Bliss Murphy Cancer Centre; Oncology</name>
      <address>
        <city>St. John's</city>
        <state>Newfoundland and Labrador</state>
        <zip>A1B 3V6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials</name>
      <address>
        <city>Barrie</city>
        <state>Ontario</state>
        <zip>L4M 6M2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Regional Cancer Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southlake Regional Health Center; Community Care Clinic / Oncology</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <zip>L3Y 2P9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Michael'S Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Maisonneuve- Rosemont; Oncology</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mcgill University - Royal Victoria Hospital; Oncology</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3A 1A1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Hospital Chinese Academy of Medical Sciences.</name>
      <address>
        <city>Beijing</city>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen Memorial Hospital</name>
      <address>
        <city>Guangzhou</city>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yet-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Cancer Hospital</name>
      <address>
        <city>Nanjing City</city>
        <zip>211100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai City</city>
        <zip>200120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Cancer Hospital</name>
      <address>
        <city>Tianjin</city>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Zhejiang</city>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Centre Zagreb</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herlev Hospital; Afdeling for Kræftbehandling</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nordsjællands Hospital, Hillerød, Onkologisk Afdeling</name>
      <address>
        <city>Hillerod</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet; Onkologisk Klinik</name>
      <address>
        <city>København Ø</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense Universitetshospital, Onkologisk Afdeling R</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium</name>
      <address>
        <city>Roskilde</city>
        <zip>4000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vejle Sygehus; Onkologisk Afdeling</name>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Metropolitano de Santiago</name>
      <address>
        <city>Santiago</city>
        <zip>51000</zip>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Alcivar, torre 1;Private office</name>
      <address>
        <city>Guayaquil</city>
        <zip>EC090114</zip>
        <country>Ecuador</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Solca Portoviejo; Oncologia</name>
      <address>
        <city>Portoviejo</city>
        <zip>EC130104</zip>
        <country>Ecuador</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Estonia Medical Centre Foundation; Oncology Center</name>
      <address>
        <city>Tallinn</city>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsingin yliopistollinen keskussairaala</name>
      <address>
        <city>Helsinki</city>
        <zip>00290</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KYS Sadesairaala; Syopatautien poliklinikka</name>
      <address>
        <city>Kuopio</city>
        <zip>70210</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampere University Hospital; Dept of Oncology</name>
      <address>
        <city>Tampere</city>
        <zip>33520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turku Uni Central Hospital; Oncology Clinics</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique De L Europe; Radiotherapie Chimiotherapie</name>
      <address>
        <city>Amiens</city>
        <zip>80090</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO Paul Papin; Oncologie Medicale.</name>
      <address>
        <city>Angers</city>
        <zip>49055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Sainte Catherine</name>
      <address>
        <city>Avignon</city>
        <zip>84082</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Jean Minjoz - CHU de Besançon</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Tivoli; Chimiotherapie Radiotherapie</name>
      <address>
        <city>Bordeaux</city>
        <zip>33030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonie; Oncologie</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie</name>
      <address>
        <city>Bordeaux</city>
        <zip>33077</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cli De La Porte De Saint Cloud; Hop De Jour De Chimiotherapie</name>
      <address>
        <city>Boulogne-billancourt</city>
        <zip>92100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Morvan; Oncologie - Radiotherapie</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Francois Baclesse; Radiotherapie</name>
      <address>
        <city>Caen</city>
        <zip>14076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin; Oncologie</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63011</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Georges Francois Leclerc; Oncologie 3</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hartmann</name>
      <address>
        <city>Levallois Perret</city>
        <zip>92300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret; Senologie</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Chenieux; Oncology</name>
      <address>
        <city>Limoges</city>
        <zip>87039</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Bretagne Sud Site Scorff; Oncologie Medicale</name>
      <address>
        <city>Lorient</city>
        <zip>56100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli Calmettes; Oncologie Medicale</name>
      <address>
        <city>Marseille</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Layne; Medecine Ambulatoire</name>
      <address>
        <city>Mont-de-marsan</city>
        <zip>40024</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Val Aurelle Paul Lamarque; Recherche Clinique</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne; Hopital De Jour A2</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie; Oncologie Medicale</name>
      <address>
        <city>Paris</city>
        <zip>75231</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOPITAL TENON; Cancerologie Medicale</name>
      <address>
        <city>Paris</city>
        <zip>75970</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique Francheville; Med Chimiotherapie Radiotherapie</name>
      <address>
        <city>Perigueux</city>
        <zip>24000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Catalan D' Oncologie</name>
      <address>
        <city>Perpignan</city>
        <zip>66000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Armoricaine Radiologie; Hopital de Jour</name>
      <address>
        <city>Plerin</city>
        <zip>22190</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pole Regional De Cancerologie</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jean Godinot; Oncologie Medicale</name>
      <address>
        <city>Reims CEDEX</city>
        <zip>51056</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique De Courlancy; Centre Radiotherapie Oncologie</name>
      <address>
        <city>Reims</city>
        <zip>51057</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Eugene Marquis; Unite Huguenin</name>
      <address>
        <city>Rennes</city>
        <zip>35042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel; Oncologie Medicale</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ico Rene Gauducheau; Oncologie</name>
      <address>
        <city>Saint Herblain</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Rene Huguenin; CONSULT SPECIALISEES</name>
      <address>
        <city>St Cloud</city>
        <zip>92210</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Paul Strauss; Oncologie Medicale</name>
      <address>
        <city>Strasbourg</city>
        <zip>67065</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Claudius Regaud; Departement Oncologie Medicale</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur; Oncologie Medicale</name>
      <address>
        <city>Toulouse</city>
        <zip>31076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Henry S Kaplan - CHU Bretonneau ; service oncologie</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Alexis Vautrin; Oncologie Medicale</name>
      <address>
        <city>Vandoeuvre-les-nancy</city>
        <zip>54519</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy; Pathologie Mammaire</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter</name>
      <address>
        <city>Augsburg</city>
        <zip>86150</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dres. Schilling &amp; Till</name>
      <address>
        <city>Berlin</city>
        <zip>10317</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schwerpunktpraxis Onkologie/Hämatologie Dr. Dirk Pott, Dr. Christian Tirier und Carla Verena u.w.</name>
      <address>
        <city>Bottrop</city>
        <zip>46236</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkozentrum Dres. Göhler</name>
      <address>
        <city>Dresden</city>
        <zip>01127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dres. Joerg Weniger, Annette Bittrich und Berit Schuetze</name>
      <address>
        <city>Erfurt</city>
        <zip>99085</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Erlangen; Frauenklinik</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OncoResearch Lerchenfeld GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>22081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOPA MVZ GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>22767</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut für Versorgungsforschung in der Onkologie GbR Koblenz</name>
      <address>
        <city>Koblenz</city>
        <zip>56068</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Leverkusen; Med. Klinik III / Onkologie</name>
      <address>
        <city>Leverkusen</city>
        <zip>51375</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde</name>
      <address>
        <city>Muenchen</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie &amp; Geburtshilfe</name>
      <address>
        <city>Offenbach</city>
        <zip>63069</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis für Hämatologie und Onkologie</name>
      <address>
        <city>Porta Westfalica</city>
        <zip>32457</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsfrauenklinik; Und Poliklinik Am Klinikum</name>
      <address>
        <city>Rostock</city>
        <zip>18059</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Tübingen; Frauenklinik</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie</name>
      <address>
        <city>Wiesbaden</city>
        <zip>65199</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag &amp; Schöttker</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Heraklion</name>
      <address>
        <city>Crete</city>
        <zip>711 10</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uni Hospital of Ioannina; Oncology Dept.</name>
      <address>
        <city>Ioannina</city>
        <zip>455 00</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Patras Medical Oncology</name>
      <address>
        <city>Patras</city>
        <zip>265 04</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Papageorgiou General Hospital; Medical Oncology</name>
      <address>
        <city>Thessaloniki</city>
        <zip>564 29</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Oncológico Sixtino / Centro Oncológico SA</name>
      <address>
        <city>Guatemala</city>
        <zip>01010</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital; Oncology</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hosp; Dept. Of Clinical Onc</name>
      <address>
        <city>Shatin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogyi, Orszagos Gyogyszereszeti Intezet</name>
      <address>
        <city>Budapest</city>
        <zip>1051</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szent Imre Hospital; Dept. of Oncology</name>
      <address>
        <city>Budapest</city>
        <zip>1115</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely</name>
      <address>
        <city>Budapest</city>
        <zip>H-1077</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaposi Mor County Hospital; Dept. of Oncology</name>
      <address>
        <city>Kaposvar</city>
        <zip>7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landspitali University Hospital, Department of Medical Oncology</name>
      <address>
        <city>Reykjavik</city>
        <zip>101</zip>
        <country>Iceland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cipto Mangunkusumo General Hospital; Hematology &amp; Oncology</name>
      <address>
        <city>Jakarta</city>
        <zip>10430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dharmais National Cancer Center</name>
      <address>
        <city>Jakarta</city>
        <zip>11420</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MRCCC Siloam Semanggi Hospital</name>
      <address>
        <city>Jakarta</city>
        <zip>12930</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cork Uni Hospital; Oncology Dept</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent'S Uni Hospital; Medical Oncology</name>
      <address>
        <city>Dublin</city>
        <zip>4</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mater Misericordiae Uni Hospital; Oncology</name>
      <address>
        <city>Dublin</city>
        <zip>7</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Limerick - Oncology</name>
      <address>
        <city>Limerick</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Giuseppe Moscati</name>
      <address>
        <city>Avellino</city>
        <state>Campania</state>
        <zip>83100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori Fondazione G. Pascale</name>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università degli Studi Federico II; Clinica di Oncologia Medica</name>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Bellaria; U.O. Oncologia Medica</name>
      <address>
        <city>Bologna</city>
        <state>Emilia-Romagna</state>
        <zip>40133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico di Modena</name>
      <address>
        <city>Modena</city>
        <state>Emilia-Romagna</state>
        <zip>40124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia</name>
      <address>
        <city>Piacenza</city>
        <state>Emilia-Romagna</state>
        <zip>29100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RCCS - Centro di Riferimento; Oncologia Medica B</name>
      <address>
        <city>Aviano (PN)</city>
        <state>Friuli-Venezia Giulia</state>
        <zip>33081</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Divisione Onc Med dell'Azienda</name>
      <address>
        <city>Udine</city>
        <state>Friuli-Venezia Giulia</state>
        <zip>33100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S.S. Trinità Nuovo; Divisione Oncologia</name>
      <address>
        <city>Sora</city>
        <state>Lazio</state>
        <zip>03039</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A</name>
      <address>
        <city>Genova</city>
        <state>Liguria</state>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit</name>
      <address>
        <city>Cremona</city>
        <state>Lombardia</state>
        <zip>26100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST DI LECCO; Oncologia Medica</name>
      <address>
        <city>Lecco</city>
        <state>Lombardia</state>
        <zip>23900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele; Medical Oncology</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo Di Oncologia</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica</name>
      <address>
        <city>Pavia</city>
        <state>Lombardia</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Casa di Cura Multimedica S.p.A.; Dipartimento Oncologico</name>
      <address>
        <city>Sesto San Giovanni (MI)</city>
        <state>Lombardia</state>
        <zip>20099</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico</name>
      <address>
        <city>Candiolo</city>
        <state>Piemonte</state>
        <zip>10060</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Maggiore Della Carita; Oncologia Medica</name>
      <address>
        <city>Novara</city>
        <state>Piemonte</state>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Antonio Perrino; Oncologia Medica</name>
      <address>
        <city>Brindisi</city>
        <state>Puglia</state>
        <zip>72100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Vito Fazzi; Div. Oncoematologia</name>
      <address>
        <city>Lecce</city>
        <state>Puglia</state>
        <zip>73100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica</name>
      <address>
        <city>Catania</city>
        <state>Sicilia</state>
        <zip>95122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U Careggi</name>
      <address>
        <city>Florence</city>
        <state>Toscana</state>
        <zip>50124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia</name>
      <address>
        <city>Pontedera</city>
        <state>Toscana</state>
        <zip>56025</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Misericordia E Dolce; Oncologia Medica</name>
      <address>
        <city>Prato</city>
        <state>Toscana</state>
        <zip>59100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica</name>
      <address>
        <city>Perugia</city>
        <state>Umbria</state>
        <zip>06156</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Civile; Oncologia Medica</name>
      <address>
        <city>Camposampiero</city>
        <state>Veneto</state>
        <zip>35012</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Busonera; Oncologia Medica</name>
      <address>
        <city>Padova</city>
        <state>Veneto</state>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.</name>
      <address>
        <city>Verona</city>
        <state>Veneto</state>
        <zip>37126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>41404</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon Medical School Gil Medical Center; Medical Oncology</name>
      <address>
        <city>Incheon</city>
        <zip>405-760</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonsei University Severance Hospital; Medical Oncology</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital; Oncology Haemotology</name>
      <address>
        <city>Seoul</city>
        <zip>136-705</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHL Hopital Municipal; Oncology</name>
      <address>
        <city>Luxembourg</city>
        <zip>1210</zip>
        <country>Luxembourg</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de México</name>
      <address>
        <city>Mexico City</city>
        <state>Mexico CITY (federal District)</state>
        <zip>06726</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medica Sur Centro Oncologico Integral</name>
      <address>
        <city>D.f.</city>
        <zip>14050</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Hmg Coyoacan</name>
      <address>
        <city>DF</city>
        <zip>04110</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CENTRO MÉDICO NACIONAL SIGLO XXI; Hospital de Especialidades Oncología</name>
      <address>
        <city>Mexico City</city>
        <zip>06725</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inst. Nacional de Cancerologia; Investigacion Clinica</name>
      <address>
        <city>Mexico City</city>
        <zip>14000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán</name>
      <address>
        <city>Mexico City</city>
        <zip>Tlalpan 14000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde</name>
      <address>
        <city>Amsterdam</city>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amphia Ziekenhuis</name>
      <address>
        <city>Breda</city>
        <zip>4819 EV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MC Haaglanden; Oncologie</name>
      <address>
        <city>Den Haag</city>
        <zip>2512 VA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deventer Ziekenhuis; Interne Geneeskunde</name>
      <address>
        <city>Deventer</city>
        <zip>7416 SE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuisgroep Twente, Hengelo</name>
      <address>
        <city>Hengelo</city>
        <zip>7555 DL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spaarne Ziekenhuis; Inwendige Geneeskunde</name>
      <address>
        <city>Hoofddorp</city>
        <zip>2134 TM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Leeuwarden; Interne</name>
      <address>
        <city>Leeuwarden</city>
        <zip>8934 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orbis Medisch Centrum; Inwendige Geneeskunde</name>
      <address>
        <city>Sittard-Geleen</city>
        <zip>6162 BG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Twee Steden Ziekenhuis - Locatie Tilburg; Interne Geneesekunde</name>
      <address>
        <city>Tilburg</city>
        <zip>5042 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo Universitetssykehus HF; Ullevål sykehus</name>
      <address>
        <city>Oslo</city>
        <zip>0450</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hemato Oncologico Panama</name>
      <address>
        <city>Panama</city>
        <zip>0832</zip>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Oncologico America</name>
      <address>
        <city>Panama</city>
        <zip>0834-02723</zip>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto;Oncologico Miraflores</name>
      <address>
        <city>Lima</city>
        <zip>18</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de Especialidades Medicas</name>
      <address>
        <city>Lima</city>
        <zip>Lima 41</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej</name>
      <address>
        <city>Bialystok</city>
        <zip>15-027</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny POO im. ks. B.Markiewicza; Dzienny Oddz Chemioter i Hematologii Onkol</name>
      <address>
        <city>Brzozów</city>
        <zip>36-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Świętokrzyskie Centrum Onkologii; Dział Chemioterapii</name>
      <address>
        <city>Kielce</city>
        <zip>25-734</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii</name>
      <address>
        <city>Kraków</city>
        <zip>30-688</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii</name>
      <address>
        <city>Otwock</city>
        <zip>05-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewódzki Szpital Specjalistyczny Nr 3</name>
      <address>
        <city>Rybnik</city>
        <zip>44-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPO de Lisboa; Servico de Oncologia Medica</name>
      <address>
        <city>Lisboa</city>
        <zip>1099-023</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital da Luz; Departamento de Oncologia Medica</name>
      <address>
        <city>Lisboa</city>
        <zip>1500-650</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPO do Porto; Servico de Oncologia Medica</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A</name>
      <address>
        <city>Bratislava</city>
        <zip>833 10</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultna nemocnica Trencín; Onkologicke odd.</name>
      <address>
        <city>Trencin</city>
        <zip>911 71</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Oncology Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Elche; Servicio de Oncologia</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Elda; Servicio de Oncologia</name>
      <address>
        <city>Elda</city>
        <state>Alicante</state>
        <zip>03600</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ. Central de Asturias; Servicio de Oncologia</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corporacio Sanitaria Parc Tauli; Servicio de Oncologia</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>8208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Jerez de la Frontera; Servicio de Oncologia</name>
      <address>
        <city>Jerez de La Frontera</city>
        <state>Cadiz</state>
        <zip>11407</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofia; Servicio de Oncologia</name>
      <address>
        <city>Córdoba</city>
        <state>Cordoba</state>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Donostia; Servicio de Oncologia Medica</name>
      <address>
        <city>San Sebastian</city>
        <state>Guipuzcoa</state>
        <zip>20080</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Son Espases</name>
      <address>
        <city>Palma De Mallorca</city>
        <state>Islas Baleares</state>
        <zip>07014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <state>LAS Palmas</state>
        <zip>35016</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <state>LAS Palmas</state>
        <zip>35020</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Severo Ochoa; Servicio de Oncologia</name>
      <address>
        <city>Leganes</city>
        <state>Madrid</state>
        <zip>28911</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quiron de Madrid; Servicio de Oncologia</name>
      <address>
        <city>Pozuelo de Alarcon</city>
        <state>Madrid</state>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Xeral Cíes; Servicio de Oncologia</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Sant Joan de Reus; Servicio de Oncologia</name>
      <address>
        <city>Reus</city>
        <state>Tarragona</state>
        <zip>43204</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Cruces; Servicio de Oncologia</name>
      <address>
        <city>Bilbao</city>
        <state>Vizcaya</state>
        <zip>48903</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Univ. de Alicante; Servicio de Oncologia</name>
      <address>
        <city>Alicante</city>
        <zip>3010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar; Servicio de Oncologia</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quiron Barcelona; Servicio de Oncologia</name>
      <address>
        <city>Barcelona</city>
        <zip>08024</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Pedro De Alcantara; Servicio de Oncologia</name>
      <address>
        <city>Caceres</city>
        <zip>10003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia</name>
      <address>
        <city>Girona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario San Cecilio; Servicio de Oncologia</name>
      <address>
        <city>Granada</city>
        <zip>18003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia</name>
      <address>
        <city>Jaen</city>
        <zip>23007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología</name>
      <address>
        <city>La Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia</name>
      <address>
        <city>Lerida</city>
        <zip>25198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramon y Cajal; Servicio de Oncologia</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Pontevedra; Servicio de Oncologia</name>
      <address>
        <city>Pontevedra</city>
        <zip>36002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Valenciano Oncologia; Oncologia Medica</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Valencia; Servicio de oncologia</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet; Servicio Oncologia</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Hospital; Oncology - Radiumhemmet</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norrlands universitetssjukhus; Onkologkliniken</name>
      <address>
        <city>Umeå</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung Uni Hospital; Surgery</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chi-Mei Medical Centre; Hematology &amp; Oncology</name>
      <address>
        <city>Tainan</city>
        <zip>710</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VETERANS GENERAL HOSPITAL; Department of General Surgery</name>
      <address>
        <city>Taipei</city>
        <zip>00112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Surgery, King Chulalongkorn Memorial Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pramongkutklao Hospital; Medicine - Medical Oncology Unit</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gazi Uni Medical Faculty Hospital; Oncology Dept</name>
      <address>
        <city>Ankara</city>
        <zip>06500</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gaziantep University Medical Faculty, Medical Oncology Department</name>
      <address>
        <city>Gaziantep</city>
        <zip>27310</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bezmialem Vakif Univ Medical; Bezmialem Vakif Univ T</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology</name>
      <address>
        <city>Istanbul</city>
        <zip>34300</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul Uni of Medicine Faculty; Oncology Dept</name>
      <address>
        <city>Istanbul</city>
        <zip>34390</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department</name>
      <address>
        <city>Istanbul</city>
        <zip>34865</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marmara Uni Faculty of Medicine; Medical Oncology</name>
      <address>
        <city>Istanbul</city>
        <zip>34890</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ege Uni Medical Faculty Hospital; Oncology Dept</name>
      <address>
        <city>Izmir</city>
        <zip>35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokuz Eylul Uni ; Medical Oncology</name>
      <address>
        <city>Izmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kocaeli University Faculty of Medicine; Medical oncology</name>
      <address>
        <city>Izmit</city>
        <zip>31380</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tawam Hospital</name>
      <address>
        <city>Al Ain</city>
        <zip>15258</zip>
        <country>United Arab Emirates</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aberdeen Royal Infirmary</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB25 2ZN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Birmingham Queen Elizabeth Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B17 0NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kent &amp; Canterbury Hospital</name>
      <address>
        <city>Canterbury</city>
        <zip>CT1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital coventry; Oncology Department</name>
      <address>
        <city>Coventry</city>
        <zip>CV2 2DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastborne District General Hospital</name>
      <address>
        <city>Eastbourne</city>
        <zip>BN21 2UD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western General Hospital; Clinical Oncology</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Margaret'S Hospital; Breast Unit</name>
      <address>
        <city>Epping</city>
        <zip>CM16 6TN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Devon &amp; Exeter Hospital; Oncology Centre</name>
      <address>
        <city>Exeter</city>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beatson West of Scotland Cancer Centre</name>
      <address>
        <city>Glasgow</city>
        <zip>G12 0YN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diana Princess of Wales Hosp.</name>
      <address>
        <city>Grimsby</city>
        <zip>DN33 2BA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huddersfield Royal Infirmary</name>
      <address>
        <city>Huddersfield</city>
        <zip>HD3 3EA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Castle Hill Hospital; The Queen's Centre for Oncology &amp; Haematology</name>
      <address>
        <city>Hull</city>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ipswich Hospital; Oncology Pharmacy</name>
      <address>
        <city>Ipswich</city>
        <zip>IP4 5PD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust</name>
      <address>
        <city>Lancaster</city>
        <zip>LA1 4RP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital; Dept of Oncology</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guys &amp; St Thomas Hospital; Department of Oncology</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George'S Hospital; Oncology Research Office /Oncology Opd</name>
      <address>
        <city>London</city>
        <zip>SW17 ORE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute</name>
      <address>
        <city>London</city>
        <zip>W1G 6AD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maidstone &amp; Tonbridge Wells Hospital; Kent Oncology Center</name>
      <address>
        <city>Maidstone</city>
        <zip>ME16 9QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christie Hospital; Breast Cancer Research Office</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4QL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Hospital</name>
      <address>
        <city>Middlesex</city>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plymouth Oncology Centre; Clinical Trials Unit</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Alexandra Hospital, Portsmouth</name>
      <address>
        <city>Portsmouth</city>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Hospital; Oncology</name>
      <address>
        <city>Romford</city>
        <zip>RM7 0AG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weston Park Hospital; Cancer Clinical Trials Centre</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2SJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Shrewsbury Hospital</name>
      <address>
        <city>Shrewsbury</city>
        <zip>SY3 8XQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singleton Hospital; Pharmacy</name>
      <address>
        <city>Swansea</city>
        <zip>SA2 8QA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yeovil District Hospital; Macmillan Cancer Unit</name>
      <address>
        <city>Yeovil</city>
        <zip>BA21 4AT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>York District Hospital</name>
      <address>
        <city>York</city>
        <zip>YO31 8HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Mastologia y Atencion a la Mujer</name>
      <address>
        <city>Barcelona</city>
        <zip>6001</zip>
        <country>Venezuela</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Oncológico Luis Razetti</name>
      <address>
        <city>Caracas</city>
        <zip>1010</zip>
        <country>Venezuela</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Oncologia y Hematologia UCV</name>
      <address>
        <city>Caracas</city>
        <zip>1020</zip>
        <country>Venezuela</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>China</country>
    <country>Croatia</country>
    <country>Denmark</country>
    <country>Dominican Republic</country>
    <country>Ecuador</country>
    <country>Estonia</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Guatemala</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Iceland</country>
    <country>Indonesia</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Luxembourg</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Panama</country>
    <country>Peru</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Slovakia</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>United Arab Emirates</country>
    <country>United Kingdom</country>
    <country>Venezuela</country>
  </location_countries>
  <removed_countries>
    <country>India</country>
  </removed_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <results_first_submitted>July 14, 2021</results_first_submitted>
  <results_first_submitted_qc>July 14, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 5, 2021</results_first_posted>
  <last_update_submitted>March 31, 2022</last_update_submitted>
  <last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2022</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>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trastuzumab</mesh_term>
    <mesh_term>Ado-Trastuzumab Emtansine</mesh_term>
    <mesh_term>Maytansine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT01702571/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT01702571/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Cohort 1 has 2003 participants and Cohort 2 has 182 participants representing the total enrollment study number. Cohort 1 was conducted in 281 centers in 40 countries worldwide whereas Cohort 2 was conducted in an Asian population in 14 centers in China, Thailand and Indonesia.</recruitment_details>
      <pre_assignment_details>Two participants (one in Corhort 1 and Corhot 2) were not included in the safety population as one didn't receive study treatment and one did not qualify under the inclusion criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Trastuzumab Emtansine (All Participants)</title>
          <description>This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
        </group>
        <group group_id="P2">
          <title>Trastuzumab Emtansine (Asian Participants)</title>
          <description>This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2003"/>
                <participants group_id="P2" count="182"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="494">For one participant, the site incorrectly answered the question 'Did the participant complete follow-up as per protocol?' It was answered No, however the participant was in survival follow-up and the site should have answered Yes. This participant is wrongly counted in the 'discontinued from study' number.</participants>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1509"/>
                <participants group_id="P2" count="117"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1067"/>
                <participants group_id="P2" count="76"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="144"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event/Unacceptable Toxicity</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator Decision</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not Classifiable</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>On Study Treatment At Lplv/Cohort 1</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>On Study Treatment At Lplv/Cohort 2</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Safety FU Done &lt; 3 Months Prior To CCOD</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Termination By Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="177"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Trastuzumab Emtansine (All Participants)</title>
          <description>This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
        </group>
        <group group_id="B2">
          <title>Trastuzumab Emtansine (Asian Participants)</title>
          <description>This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2003"/>
            <count group_id="B2" value="182"/>
            <count group_id="B3" value="2185"/>
          </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="54.5" spread="11.4"/>
                    <measurement group_id="B2" value="49.1" spread="10.1"/>
                    <measurement group_id="B3" value="54.1" spread="11.4"/>
                  </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="1989"/>
                    <measurement group_id="B2" value="182"/>
                    <measurement group_id="B3" value="2171"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Race</description>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1397"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1397"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="182"/>
                    <measurement group_id="B3" value="254"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N/A as per local regulation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="466"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="466"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Ethnicity</description>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hispanic/Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="300"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chinese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="147"/>
                    <measurement group_id="B3" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N/A as per local regulation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="997"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="1013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="417"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="436"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indian (Indian subcontinent)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="247"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="247"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Adverse Events of Primary Interest (AEPIs)</title>
        <description>The AEPIs in this study were defined as the following: adverse events (AEs) Grade &gt;/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade &gt;/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.</description>
        <time_frame>Baseline up to approximately 7 years</time_frame>
        <population>The safety population included all participants who had received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Trastuzumab Emtansine (All Participants)</title>
            <description>This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Trastuzumab Emtansine (Asian Participants)</title>
            <description>This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adverse Events of Primary Interest (AEPIs)</title>
          <description>The AEPIs in this study were defined as the following: adverse events (AEs) Grade &gt;/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade &gt;/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.</description>
          <population>The safety population included all participants who had received at least 1 dose of study medication.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2002"/>
                <count group_id="O2" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1" lower_limit="21.2" upper_limit="25.0"/>
                    <measurement group_id="O2" value="51.4" lower_limit="43.9" upper_limit="58.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Specific AEPIs</title>
        <description>The AEPIs in this study were defined as the following: adverse events (AEs) Grade &gt;/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade &gt;/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.</description>
        <time_frame>Baseline up to approximately 7 years</time_frame>
        <population>The safety population included all participants who had received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Trastuzumab Emtansine (All Participants)</title>
            <description>This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Trastuzumab Emtansine (Asian Participants)</title>
            <description>This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Specific AEPIs</title>
          <description>The AEPIs in this study were defined as the following: adverse events (AEs) Grade &gt;/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade &gt;/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.</description>
          <population>The safety population included all participants who had received at least 1 dose of 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="2002"/>
                <count group_id="O2" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs Grade &gt;/= 3 for hepatic events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9"/>
                    <measurement group_id="O2" value="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs Grade &gt;/= 3 for allergic reactions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                    <measurement group_id="O2" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs Grade &gt;/= 3 for thrombocytopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7"/>
                    <measurement group_id="O2" value="36.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs Grade &gt;/= 3 for hemorrhage events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                    <measurement group_id="O2" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs Grade &gt;/= 3 related to trastuzumab emtansine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.4"/>
                    <measurement group_id="O2" value="48.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pneumonitis of all grades</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                    <measurement group_id="O2" value="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Adverse Events of Special Interest (AESIs)</title>
        <description>AESIs included: 1) Potential drug-induced liver injury, which included any potential case of drug-induced liver injury as, assessed by laboratory criteria for Hy's law (AST and/or ALT elevations that were &gt;3 × ULN, Concurrent elevation of total bilirubin &gt;2 × ULN (or clinical jaundice if total bilirubin measures were not available), except in participants with documented Gilbert's syndrome. Those with Gilbert's syndrome, elevation of direct bilirubin &gt;2 × ULN was used instead. 2) Suspected transmission of an infectious agent by study drug was defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic. A transmission of an infectious agent suspected from clinical symptoms or laboratory findings indicating an infection in a participant exposed to a medicinal product.</description>
        <time_frame>Baseline up to approximately 7 years</time_frame>
        <population>The safety population included all participants who had received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Trastuzumab Emtansine (All Participants)</title>
            <description>This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Trastuzumab Emtansine (Asian Participants)</title>
            <description>This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adverse Events of Special Interest (AESIs)</title>
          <description>AESIs included: 1) Potential drug-induced liver injury, which included any potential case of drug-induced liver injury as, assessed by laboratory criteria for Hy's law (AST and/or ALT elevations that were &gt;3 × ULN, Concurrent elevation of total bilirubin &gt;2 × ULN (or clinical jaundice if total bilirubin measures were not available), except in participants with documented Gilbert's syndrome. Those with Gilbert's syndrome, elevation of direct bilirubin &gt;2 × ULN was used instead. 2) Suspected transmission of an infectious agent by study drug was defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic. A transmission of an infectious agent suspected from clinical symptoms or laboratory findings indicating an infection in a participant exposed to a medicinal product.</description>
          <population>The safety population included all participants who had received at least 1 dose of 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="2002"/>
                <count group_id="O2" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Potential drug-induced liver injury</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                    <measurement group_id="O2" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suspected transmission of an infectious agent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment</title>
        <description>Progression free survival is defined as the time (in months) between the date of first dose and the date of disease progression or death from any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of &gt;/= 5 millimeters (mm).</description>
        <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)</time_frame>
        <population>Intent to Treat (ITT) Population included all participants enrolled in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Trastuzumab Emtansine (All Participants)</title>
            <description>This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Trastuzumab Emtansine (Asian Participants)</title>
            <description>This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment</title>
          <description>Progression free survival is defined as the time (in months) between the date of first dose and the date of disease progression or death from any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of &gt;/= 5 millimeters (mm).</description>
          <population>Intent to Treat (ITT) Population included all participants enrolled in the study.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2003"/>
                <count group_id="O2" value="182"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" lower_limit="5.8" upper_limit="7.6"/>
                    <measurement group_id="O2" value="5.7" lower_limit="5.5" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Overall survival is defined as time to death, which is the time from the date of dosing until the date of death, regardless of the cause of death.</description>
        <time_frame>Baseline until death (up to approximately 7 years)</time_frame>
        <population>ITT Population included all participants enrolled in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Trastuzumab Emtansine (All Participants)</title>
            <description>This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Trastuzumab Emtansine (Asian Participants)</title>
            <description>This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Overall survival is defined as time to death, which is the time from the date of dosing until the date of death, regardless of the cause of death.</description>
          <population>ITT Population included all participants enrolled in the study.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2003"/>
                <count group_id="O2" value="182"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.2" lower_limit="25.5" upper_limit="28.7"/>
                    <measurement group_id="O2" value="29.5" lower_limit="21.1" upper_limit="NA">The confidence interval has no upper limit</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment</title>
        <description>Best Overall Response reported here is the Best confirmed Overall Response. To be assigned a status of PR or CR, i.e., to be a responder, changes in tumor measurements had to be confirmed by repeat assessments that had to be performed no less than 4 weeks after the criteria for response were first met, i.e., participants needed to have two consecutive assessments of PR or CR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.</description>
        <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)</time_frame>
        <population>ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Trastuzumab Emtansine (All Participants)</title>
            <description>This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Trastuzumab Emtansine (Asian Participants)</title>
            <description>This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment</title>
          <description>Best Overall Response reported here is the Best confirmed Overall Response. To be assigned a status of PR or CR, i.e., to be a responder, changes in tumor measurements had to be confirmed by repeat assessments that had to be performed no less than 4 weeks after the criteria for response were first met, i.e., participants needed to have two consecutive assessments of PR or CR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.</description>
          <population>ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1613"/>
                <count group_id="O2" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.3" lower_limit="27.1" upper_limit="31.6"/>
                    <measurement group_id="O2" value="29.6" lower_limit="22.8" upper_limit="37.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1</title>
        <description>Clinical Benefit was defined as CR plus PR plus SD. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.</description>
        <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)</time_frame>
        <population>ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Trastuzumab Emtansine (All Participants)</title>
            <description>This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Trastuzumab Emtansine (Asian Participants)</title>
            <description>This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1</title>
          <description>Clinical Benefit was defined as CR plus PR plus SD. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.</description>
          <population>ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1613"/>
                <count group_id="O2" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.1" lower_limit="44.7" upper_limit="49.6"/>
                    <measurement group_id="O2" value="39.6" lower_limit="32.2" upper_limit="47.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR) According to RECIST v 1.1</title>
        <description>DOR is defined as the period from the date of initial confirmed PR or CR (whichever occurs first) until the date of PD or death from any cause. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of &gt;/= 5 millimeters (mm).</description>
        <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)</time_frame>
        <population>ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Trastuzumab Emtansine (All Participants)</title>
            <description>This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Trastuzumab Emtansine (Asian Participants)</title>
            <description>This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR) According to RECIST v 1.1</title>
          <description>DOR is defined as the period from the date of initial confirmed PR or CR (whichever occurs first) until the date of PD or death from any cause. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of &gt;/= 5 millimeters (mm).</description>
          <population>ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1613"/>
                <count group_id="O2" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.8" lower_limit="12.2" upper_limit="15.0"/>
                    <measurement group_id="O2" value="14.2" lower_limit="11.1" upper_limit="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Response According to RECIST v 1.1</title>
        <description>Time to Response is defined as the time from first dose to first documentation of confirmed PR or CR (whichever occurs first). CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.</description>
        <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)</time_frame>
        <population>ITT Population included all participants enrolled in the study. Only responders were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Trastuzumab Emtansine (All Participants)</title>
            <description>This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Trastuzumab Emtansine (Asian Participants)</title>
            <description>This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Response According to RECIST v 1.1</title>
          <description>Time to Response is defined as the time from first dose to first documentation of confirmed PR or CR (whichever occurs first). CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.</description>
          <population>ITT Population included all participants enrolled in the study. Only responders were included in the analysis.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="473"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.3" lower_limit="11.8" upper_limit="38.2"/>
                    <measurement group_id="O2" value="8.3" lower_limit="5.7" upper_limit="NA">The confidence interval has no upper limit</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Hospital Visits</title>
        <description>The number of hospital visits were recorded to evaluate the resoruce expenditures while participants were on study treatment.</description>
        <time_frame>Baseline up to approximately 7 years</time_frame>
        <population>The safety population included all participants who had received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Trastuzumab Emtansine (All Participants)</title>
            <description>This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Trastuzumab Emtansine (Asian Participants)</title>
            <description>This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Hospital Visits</title>
          <description>The number of hospital visits were recorded to evaluate the resoruce expenditures while participants were on study treatment.</description>
          <population>The safety population included all participants who had received at least 1 dose of study medication.</population>
          <units>Number of Hospital Visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2002"/>
                <count group_id="O2" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="2.78"/>
                    <measurement group_id="O2" value="2.1" spread="1.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Type of Hospital Visits</title>
        <description>The type of hospital visits (intensive care unit (ICU) versus other) were recorded to evaluate the resoruce expenditures while participants were on study treatment. The number of participants with at least one ICU visit are based on the number of participants with at least one hospital visit, in each group.</description>
        <time_frame>Baseline up to approximately 7 years</time_frame>
        <population>The safety population included all participants who had received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Trastuzumab Emtansine (All Participants)</title>
            <description>This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
          <group group_id="O2">
            <title>Trastuzumab Emtansine (Asian Participants)</title>
            <description>This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Type of Hospital Visits</title>
          <description>The type of hospital visits (intensive care unit (ICU) versus other) were recorded to evaluate the resoruce expenditures while participants were on study treatment. The number of participants with at least one ICU visit are based on the number of participants with at least one hospital visit, in each group.</description>
          <population>The safety population included all participants who had received at least 1 dose of 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="2002"/>
                <count group_id="O2" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Other Hospital Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2002"/>
                    <count group_id="O2" value="181"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="558"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICU Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="558"/>
                    <count group_id="O2" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to approximately 7 years</time_frame>
      <desc>The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Trastuzumab Emtansine (All Participants)</title>
          <description>This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
        </group>
        <group group_id="E2">
          <title>Trastuzumab Emtansine (Asian Participants)</title>
          <description>This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1072" subjects_at_risk="2002"/>
                <counts group_id="E2" subjects_affected="77" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="427" subjects_at_risk="2002"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BONE MARROW FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DISSEMINATED INTRAVASCULAR COAGULATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>FEBRILE NEUTROPENIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>THROMBOCYTOPENIA</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2002"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE CORONARY SYNDROME</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ANGINA PECTORIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CARDIAC ARREST</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CARDIAC TAMPONADE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CARDIO-RESPIRATORY ARREST</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PALPITATIONS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PERICARDIAL EFFUSION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SUPRAVENTRICULAR TACHYCARDIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>VERTIGO</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>ADRENAL INSUFFICIENCY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HYPERTHYROIDISM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>BLINDNESS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CATARACT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>RETINAL VEIN THROMBOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL DISTENSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" events="12" subjects_affected="4" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ANAL FISSURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ANAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ASCITES</sub_title>
                <counts group_id="E1" events="6" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>COLITIS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DUODENAL ULCER</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DUODENAL ULCER HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DYSPHAGIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GASTRIC ANTRAL VASCULAR ECTASIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GASTRIC HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="10" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GASTRIC ULCER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GASTRITIS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GASTRITIS EROSIVE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GASTRODUODENAL ULCER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="10" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GINGIVAL BLEEDING</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GLOSSITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>LOWER GASTROINTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>MELAENA</sub_title>
                <counts group_id="E1" events="8" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>OESOPHAGEAL FISTULA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>OESOPHAGEAL VARICES HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PANCREATITIS ACUTE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PERIODONTAL DISEASE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PROCTALGIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>RECTAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SMALL INTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SMALL INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>STOMATITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SUBILEUS</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>TOOTH LOSS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>UPPER GASTROINTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="19" subjects_affected="17" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CATHETER SITE ERYTHEMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CHILLS</sub_title>
                <counts group_id="E1" events="6" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DEATH</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GENERAL PHYSICAL HEALTH DETERIORATION</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HYPERTHERMIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>IMPLANT SITE DEHISCENCE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>INFLAMMATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>INFLUENZA LIKE ILLNESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>MALAISE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>MULTIPLE ORGAN DYSFUNCTION SYNDROME</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="42" subjects_affected="13" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SUDDEN DEATH</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>CHOLECYSTITIS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CHOLESTASIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DRUG-INDUCED LIVER INJURY</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HEPATIC FAILURE</sub_title>
                <counts group_id="E1" events="10" subjects_affected="5" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HEPATIC FUNCTION ABNORMAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HEPATIC PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HEPATOTOXICITY</sub_title>
                <counts group_id="E1" events="14" subjects_affected="7" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>JAUNDICE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>NODULAR REGENERATIVE HYPERPLASIA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>NON-CIRRHOTIC PORTAL HYPERTENSION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PORTAL HYPERTENSION</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>ALLERGIC OEDEMA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HYPERSENSITIVITY</sub_title>
                <counts group_id="E1" events="6" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>ABSCESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ACINETOBACTER INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ARTHRITIS INFECTIVE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BACTERAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BACTERIAL INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BACTERIAL SEPSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BRAIN ABSCESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BREAST CELLULITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CATHETER SITE INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CLOSTRIDIUM DIFFICILE COLITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CYSTITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DENGUE HAEMORRHAGIC FEVER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DEVICE RELATED INFECTION</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ENCEPHALITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ENDOCARDITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ERYSIPELAS</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS NOROVIRUS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS VIRAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL VIRAL INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HERPES ZOSTER</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>INFECTION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>INFECTIOUS PLEURAL EFFUSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>INFECTIVE EXACERBATION OF BRONCHIECTASIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>INTERVERTEBRAL DISCITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>KLEBSIELLA BACTERAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>LISTERIOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>LIVER ABSCESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>LOWER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>MASTITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>MENINGITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>OTITIS MEDIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PERITONITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PHARYNGITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PNEUMOCOCCAL INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" events="23" subjects_affected="22" subjects_at_risk="2002"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PNEUMONIA STREPTOCOCCAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PNEUMONIA VIRAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PYELONEPHRITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PYELONEPHRITIS ACUTE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PYELONEPHRITIS CHRONIC</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>RESPIRATORY TRACT INFECTION VIRAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SEPSIS</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SEPTIC SHOCK</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SKIN INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SOFT TISSUE INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>STAPHYLOCOCCAL BACTERAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>STAPHYLOCOCCAL INFECTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>STAPHYLOCOCCAL SEPSIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>STREPTOCOCCAL INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>TRACHEOBRONCHITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>VASCULAR DEVICE INFECTION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>VIRAL INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>VIRAL UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>VULVAL ABSCESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>ANASTOMOTIC ULCER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ANKLE FRACTURE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>FEMORAL NECK FRACTURE</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>FEMUR FRACTURE</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>FOREARM FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HAND FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HEAD INJURY</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HIP FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HUMERUS FRACTURE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>INFUSION RELATED REACTION</sub_title>
                <counts group_id="E1" events="6" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>INTENTIONAL OVERDOSE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>LUMBAR VERTEBRAL FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PELVIC FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>POST PROCEDURAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>RADIATION NECROSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>RIB FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ROAD TRAFFIC ACCIDENT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SKELETAL INJURY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SPLENIC INJURY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SUBDURAL HAEMATOMA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>THERMAL BURN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>UPPER LIMB FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>WRIST FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>AMYLASE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BLOOD BILIRUBIN INCREASED</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ECG SIGNS OF MYOCARDIAL ISCHAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GAMMA-GLUTAMYLTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HEPATIC ENZYME INCREASED</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>LIVER FUNCTION TEST ABNORMAL</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>LIVER FUNCTION TEST INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>NEUTROPHIL COUNT DECREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PLATELET COUNT DECREASED</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="12" subjects_affected="8" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>TRANSAMINASES INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>FAILURE TO THRIVE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HYPERCALCAEMIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HYPERURICAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HYPOGLYCAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HYPOKALAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HYPONATRAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </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="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BONE LESION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BONE PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HAEMATOMA MUSCLE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>INTERVERTEBRAL DISC PROTRUSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>KYPHOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>MOBILITY DECREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>MUSCULAR WEAKNESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL CHEST PAIN</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>OSTEONECROSIS OF JAW</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PATHOLOGICAL FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SPINAL PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SYSTEMIC LUPUS ERYTHEMATOSUS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>BASAL CELL CARCINOMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BENIGN NEOPLASM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BREAST CANCER METASTATIC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CANCER PAIN</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>MALIGNANT MELANOMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>MENINGIOMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>METASTASES TO BONE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>METASTATIC UTERINE CANCER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>NAEVUS HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SARCOMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SKIN NEOPLASM BLEEDING</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>APHASIA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ATAXIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BRAIN OEDEMA</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CENTRAL NERVOUS SYSTEM NECROSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CEREBRAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="8" subjects_affected="4" subjects_at_risk="2002"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CEREBRAL ISCHAEMIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CEREBROVASCULAR ACCIDENT</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>EPILEPSY</sub_title>
                <counts group_id="E1" events="15" subjects_affected="8" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HAEMORRHAGE INTRACRANIAL</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HAEMORRHAGIC STROKE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HEMIPARESIS</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>IIIRD NERVE PARESIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>LEUKOENCEPHALOPATHY</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>MIGRAINE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>MOTOR DYSFUNCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>NERVOUS SYSTEM DISORDER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PARTIAL SEIZURES</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PRESYNCOPE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SCIATICA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SEIZURE</sub_title>
                <counts group_id="E1" events="11" subjects_affected="7" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>TRANSIENT ISCHAEMIC ATTACK</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>VOCAL CORD PARALYSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>DEVICE BREAKAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DEVICE EXTRUSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DEVICE LOOSENING</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>AGITATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>COMPLETED SUICIDE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CONFUSIONAL STATE</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HALLUCINATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HAEMATURIA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>NEPHROLITHIASIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>RENAL COLIC</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>RENAL FAILURE</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>RENAL INJURY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>URINARY TRACT OBSTRUCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>CYSTOCELE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>METRORRHAGIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>UTERINE HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>UTERINE POLYP</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>VAGINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE PULMONARY OEDEMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ASPIRATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ASTHMATIC CRISIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CHOKING</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" events="24" subjects_affected="7" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>EPISTAXIS</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HAEMOPTYSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>INTERSTITIAL LUNG DISEASE</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PLEURAL EFFUSION</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PLEURITIC PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PNEUMONITIS</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PNEUMOTHORAX</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PULMONARY ALVEOLAR HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PULMONARY EMBOLISM</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PULMONARY FIBROSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PULMONARY OEDEMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>RESPIRATORY DISTRESS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>RESPIRATORY TRACT HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SLEEP APNOEA SYNDROME</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>SPIDER NAEVUS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>BREAST CONSERVING SURGERY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>SCAR EXCISION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>CIRCULATORY COLLAPSE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>EMBOLISM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HAEMATOMA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ORTHOSTATIC HYPOTENSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>VENA CAVA THROMBOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>VENOUS THROMBOSIS LIMB</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1734" subjects_at_risk="2002"/>
                <counts group_id="E2" subjects_affected="170" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" events="231" subjects_affected="173" subjects_at_risk="2002"/>
                <counts group_id="E2" events="49" subjects_affected="27" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>LEUKOPENIA</sub_title>
                <counts group_id="E1" events="23" subjects_affected="19" subjects_at_risk="2002"/>
                <counts group_id="E2" events="69" subjects_affected="15" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>NEUTROPENIA</sub_title>
                <counts group_id="E1" events="151" subjects_affected="79" subjects_at_risk="2002"/>
                <counts group_id="E2" events="72" subjects_affected="17" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>THROMBOCYTOPENIA</sub_title>
                <counts group_id="E1" events="257" subjects_affected="165" subjects_at_risk="2002"/>
                <counts group_id="E2" events="157" subjects_affected="47" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" events="182" subjects_affected="139" subjects_at_risk="2002"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" events="163" subjects_affected="135" subjects_at_risk="2002"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="568" subjects_affected="394" subjects_at_risk="2002"/>
                <counts group_id="E2" events="38" subjects_affected="10" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="376" subjects_affected="252" subjects_at_risk="2002"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DRY MOUTH</sub_title>
                <counts group_id="E1" events="303" subjects_affected="283" subjects_at_risk="2002"/>
                <counts group_id="E2" events="13" subjects_affected="7" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GINGIVAL BLEEDING</sub_title>
                <counts group_id="E1" events="96" subjects_affected="83" subjects_at_risk="2002"/>
                <counts group_id="E2" events="19" subjects_affected="14" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="1204" subjects_affected="651" subjects_at_risk="2002"/>
                <counts group_id="E2" events="45" subjects_affected="28" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>STOMATITIS</sub_title>
                <counts group_id="E1" events="213" subjects_affected="160" subjects_at_risk="2002"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="408" subjects_affected="294" subjects_at_risk="2002"/>
                <counts group_id="E2" events="24" subjects_affected="17" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" events="828" subjects_affected="491" subjects_at_risk="2002"/>
                <counts group_id="E2" events="44" subjects_affected="18" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="846" subjects_affected="556" subjects_at_risk="2002"/>
                <counts group_id="E2" events="17" subjects_affected="12" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>INFLUENZA LIKE ILLNESS</sub_title>
                <counts group_id="E1" events="161" subjects_affected="107" subjects_at_risk="2002"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" events="115" subjects_affected="102" subjects_at_risk="2002"/>
                <counts group_id="E2" events="10" subjects_affected="6" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <counts group_id="E1" events="92" subjects_affected="85" subjects_at_risk="2002"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="1599" subjects_affected="339" subjects_at_risk="2002"/>
                <counts group_id="E2" events="243" subjects_affected="47" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" events="195" subjects_affected="136" subjects_at_risk="2002"/>
                <counts group_id="E2" events="13" subjects_affected="8" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="107" subjects_affected="80" subjects_at_risk="2002"/>
                <counts group_id="E2" events="18" subjects_affected="14" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="230" subjects_affected="157" subjects_at_risk="2002"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="100" subjects_affected="86" subjects_at_risk="2002"/>
                <counts group_id="E2" events="133" subjects_affected="58" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="156" subjects_affected="136" subjects_at_risk="2002"/>
                <counts group_id="E2" events="143" subjects_affected="77" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BLOOD ALKALINE PHOSPHATASE INCREASED</sub_title>
                <counts group_id="E1" events="52" subjects_affected="52" subjects_at_risk="2002"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BLOOD BILIRUBIN INCREASED</sub_title>
                <counts group_id="E1" events="171" subjects_affected="89" subjects_at_risk="2002"/>
                <counts group_id="E2" events="85" subjects_affected="30" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>GAMMA-GLUTAMYLTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="94" subjects_affected="84" subjects_at_risk="2002"/>
                <counts group_id="E2" events="31" subjects_affected="21" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>NEUTROPHIL COUNT DECREASED</sub_title>
                <counts group_id="E1" events="58" subjects_affected="36" subjects_at_risk="2002"/>
                <counts group_id="E2" events="84" subjects_affected="20" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PLATELET COUNT DECREASED</sub_title>
                <counts group_id="E1" events="124" subjects_affected="91" subjects_at_risk="2002"/>
                <counts group_id="E2" events="191" subjects_affected="55" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>TRANSAMINASES INCREASED</sub_title>
                <counts group_id="E1" events="28" subjects_affected="27" subjects_at_risk="2002"/>
                <counts group_id="E2" events="39" subjects_affected="18" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>WEIGHT DECREASED</sub_title>
                <counts group_id="E1" events="109" subjects_affected="106" subjects_at_risk="2002"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>WHITE BLOOD CELL COUNT DECREASED</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="2002"/>
                <counts group_id="E2" events="85" subjects_affected="20" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" events="398" subjects_affected="320" subjects_at_risk="2002"/>
                <counts group_id="E2" events="23" subjects_affected="16" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HYPOALBUMINAEMIA</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="2002"/>
                <counts group_id="E2" events="14" subjects_affected="11" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HYPOKALAEMIA</sub_title>
                <counts group_id="E1" events="91" subjects_affected="73" subjects_at_risk="2002"/>
                <counts group_id="E2" events="37" subjects_affected="19" subjects_at_risk="181"/>
              </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="349" subjects_affected="265" subjects_at_risk="2002"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" events="226" subjects_affected="199" subjects_at_risk="2002"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>MUSCLE SPASMS</sub_title>
                <counts group_id="E1" events="154" subjects_affected="124" subjects_at_risk="2002"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL PAIN</sub_title>
                <counts group_id="E1" events="150" subjects_affected="135" subjects_at_risk="2002"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" events="279" subjects_affected="205" subjects_at_risk="2002"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" events="169" subjects_affected="148" subjects_at_risk="2002"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="137" subjects_affected="117" subjects_at_risk="2002"/>
                <counts group_id="E2" events="17" subjects_affected="11" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" events="650" subjects_affected="454" subjects_at_risk="2002"/>
                <counts group_id="E2" events="32" subjects_affected="19" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PARAESTHESIA</sub_title>
                <counts group_id="E1" events="139" subjects_affected="128" subjects_at_risk="2002"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>PERIPHERAL SENSORY NEUROPATHY</sub_title>
                <counts group_id="E1" events="132" subjects_affected="113" subjects_at_risk="2002"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" events="134" subjects_affected="118" subjects_at_risk="2002"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" events="256" subjects_affected="220" subjects_at_risk="2002"/>
                <counts group_id="E2" events="28" subjects_affected="23" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" events="705" subjects_affected="211" subjects_at_risk="2002"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>EPISTAXIS</sub_title>
                <counts group_id="E1" events="669" subjects_affected="402" subjects_at_risk="2002"/>
                <counts group_id="E2" events="43" subjects_affected="30" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" events="113" subjects_affected="96" subjects_at_risk="2002"/>
                <counts group_id="E2" events="17" subjects_affected="12" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800 821-8590</phone>
      <email>genentech@druginfo.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/NCT01702571
org study id: MO28231
secondary id: 2012-001628-37
nct id: NCT01702571
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This two-cohort, open-label, multicenter study will assess the safety, efficacy and
      tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced
      breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and
      chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general
      participant population; Cohort 2 will include only Asian participants.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Adverse Events of Primary Interest (AEPIs)
time frame: Baseline up to approximately 7 years
description: The AEPIs in this study were defined as the following: adverse events (AEs) Grade >/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade >/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.
measure: Percentage of Participants With Specific AEPIs
time frame: Baseline up to approximately 7 years
description: The AEPIs in this study were defined as the following: adverse events (AEs) Grade >/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade >/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.
measure: Percentage of Participants With Adverse Events of Special Interest (AESIs)
time frame: Baseline up to approximately 7 years
description: AESIs included: 1) Potential drug-induced liver injury, which included any potential case of drug-induced liver injury as, assessed by laboratory criteria for Hy's law (AST and/or ALT elevations that were >3 × ULN, Concurrent elevation of total bilirubin >2 × ULN (or clinical jaundice if total bilirubin measures were not available), except in participants with documented Gilbert's syndrome. Those with Gilbert's syndrome, elevation of direct bilirubin >2 × ULN was used instead. 2) Suspected transmission of an infectious agent by study drug was defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic. A transmission of an infectious agent suspected from clinical symptoms or laboratory findings indicating an infection in a participant exposed to a medicinal product.
measure: Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment
time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
description: Progression free survival is defined as the time (in months) between the date of first dose and the date of disease progression or death from any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
measure: Overall Survival
time frame: Baseline until death (up to approximately 7 years)
description: Overall survival is defined as time to death, which is the time from the date of dosing until the date of death, regardless of the cause of death.
measure: Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment
time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
description: Best Overall Response reported here is the Best confirmed Overall Response. To be assigned a status of PR or CR, i.e., to be a responder, changes in tumor measurements had to be confirmed by repeat assessments that had to be performed no less than 4 weeks after the criteria for response were first met, i.e., participants needed to have two consecutive assessments of PR or CR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
measure: Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1
time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
description: Clinical Benefit was defined as CR plus PR plus SD. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.
measure: Duration of Response (DOR) According to RECIST v 1.1
time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
description: DOR is defined as the period from the date of initial confirmed PR or CR (whichever occurs first) until the date of PD or death from any cause. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
measure: Time to Response According to RECIST v 1.1
time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
description: Time to Response is defined as the time from first dose to first documentation of confirmed PR or CR (whichever occurs first). CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
measure: Number of Hospital Visits
time frame: Baseline up to approximately 7 years
description: The number of hospital visits were recorded to evaluate the resoruce expenditures while participants were on study treatment.
measure: Type of Hospital Visits
time frame: Baseline up to approximately 7 years
description: The type of hospital visits (intensive care unit (ICU) versus other) were recorded to evaluate the resoruce expenditures while participants were on study treatment. The number of participants with at least one ICU visit are based on the number of participants with at least one hospital visit, in each group.
arm group label: Trastuzumab Emtansine (All Participants)
arm group type: Experimental
description: This cohort will enroll all participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
arm group label: Trastuzumab Emtansine (Asian Participants)
arm group type: Experimental
description: This cohort will enroll Asian race participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
intervention type: Drug
intervention name: Trastuzumab Emtansine
description: Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenously on Day 1 of a 3-week cycle every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
arm group label: Trastuzumab Emtansine (All Participants)
arm group label: Trastuzumab Emtansine (Asian Participants)
other name: RO5304020, T-DM1, Kadcyla
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Argentina
country: Australia
country: Austria
country: Belgium
country: Brazil
country: Bulgaria
country: Canada
country: China
country: Croatia
country: Denmark
country: Dominican Republic
country: Ecuador
country: Estonia
country: Finland
country: France
country: Germany
country: Greece
country: Guatemala
country: Hong Kong
country: Hungary
country: Iceland
country: Indonesia
country: Ireland
country: Italy
country: Korea, Republic of
country: Luxembourg
country: Mexico
country: Netherlands
country: Norway
country: Panama
country: Peru
country: Poland
country: Portugal
country: Slovakia
country: Slovenia
country: Spain
country: Sweden
country: Taiwan
country: Thailand
country: Turkey
country: United Arab Emirates
country: United Kingdom
country: Venezuela
country: India
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Trastuzumab
mesh term: Ado-Trastuzumab Emtansine
mesh term: Maytansine
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 