<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/NCT01712490</url>
  </required_header>
  <id_info>
    <org_study_id>C25003</org_study_id>
    <secondary_id>2011-005450-60</secondary_id>
    <secondary_id>U1111-1161-4937</secondary_id>
    <secondary_id>12/LO/1950</secondary_id>
    <secondary_id>JapicCTI-142491</secondary_id>
    <secondary_id>REec-2013-0114</secondary_id>
    <secondary_id>1025002760</secondary_id>
    <secondary_id>C25003CTID</secondary_id>
    <nct_id>NCT01712490</nct_id>
  </id_info>
  <brief_title>A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma</brief_title>
  <official_title>A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seagen Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of&#xD;
      comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin&#xD;
      (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated&#xD;
      A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and&#xD;
      dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 9, 2012</start_date>
  <completion_date type="Anticipated">January 13, 2026</completion_date>
  <primary_completion_date type="Actual">April 20, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)</measure>
    <time_frame>Baseline until PD or death or receipt of any subsequent anticancer therapy for HL after completion of frontline therapy (approximately up to 4 years)</time_frame>
    <description>mPFS was defined as the time from the date of randomization to the date of the first of documentation of progressive disease (PD), death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for Hodgkin lymphoma (HL) after completion of frontline therapy. PD was defined as any new lesion or increase by greater than or equal to (&gt;=) 50 percent (%) of previously involved sites from nadir. Frontline therapy is the part of standard set of treatments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Baseline until death (approximately up to 4 years)</time_frame>
    <description>OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis were censored at the date last known to be alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF</measure>
    <time_frame>Baseline up to end of randomized regimen (approximately 1 year)</time_frame>
    <description>CR rate at the end of randomized regimen per investigator was defined as the percentage of participants who achieved CR at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by IRF. CR was defined as disappearance of all evidence of disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug (approximately 1 year)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Clinical Laboratory Values</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug (approximately 1 year)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free Survival (EFS) Per IRF</measure>
    <time_frame>Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years)</time_frame>
    <description>EFS was defined as the time from randomization until any cause of treatment failure: PD, premature discontinuation of randomized treatment for any reason, or death due to any cause, whichever occurs first. PD was defined as any new lesion or increase by &gt;=50% of previously involved sites from nadir per IRF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free Survival (DFS) Per IRF</measure>
    <time_frame>From CR until PD or death (approximately up to 4 years)</time_frame>
    <description>DFS per IRF was defined as the time from CR to disease progression as determined by an IRF or to death from lymphoma or acute toxicity from treatment. CR was defined as disappearance of all evidence of disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR) Per IRF</measure>
    <time_frame>Baseline up to end of randomized regimen (approximately 1 year)</time_frame>
    <description>ORR per IRF was defined as the percentage of participants who achieved CR or partial remission (PR) at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by an IRF. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) Per IRF</measure>
    <time_frame>From first documented response until PD (approximately 4 years)</time_frame>
    <description>DOR per IRF in participants with response was the time between first documentation of response (PR or CR) and PD as determined by an IRF. PD was defined as any new lesion or increase by &gt;=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Complete Remission (DOCR) Per IRF</measure>
    <time_frame>From first documentation of CR until PD (approximately 4 years)</time_frame>
    <description>DOCR per IRF in participants with CR was the time between first documentation of CR and PD as determined by an IRF. PD was defined as any new lesion or increase by &gt;=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Not in CR Per IRF Who Received Subsequent Radiation After Completion of Frontline Therapy</measure>
    <time_frame>Baseline up to end of frontline therapy (approximately 4 years)</time_frame>
    <description>CR was defined as disappearance of all evidence of disease as determined by an IRF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Remission (CR) Per IRF Rate at the End of Frontline Therapy</measure>
    <time_frame>Baseline up to end of frontline therapy (approximately 4 years)</time_frame>
    <description>CR rate at the end of frontline therapy per IRF was defined as the percentage of participants who achieved CR at the end of frontline therapy that is after completion of either randomized regimen or alternate frontline therapy as determined by an IRF. CR was defined as disappearance of all evidence of disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positron Emission Tomography (PET) Negativity Rate Per IRF at Cycle 2</measure>
    <time_frame>Cycle 2 Day 25</time_frame>
    <description>PET negativity rate at Cycle 2 was defined as the percentage of participants with negative Cycle 2 PET results defined as Deauville score less than or equal to (&lt;=) 3 at Cycle 2. The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A+AVD: Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) and Total Antibody (TAb)</measure>
    <time_frame>Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE)</measure>
    <time_frame>Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb</measure>
    <time_frame>Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin MMAE</measure>
    <time_frame>Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A+AVD: Number of Participants With Antitherapeutic Antibody (ATA) and Neutralizing Antitherapeutic Antibody (nATA) Positive for Brentuximab Vedotin</measure>
    <time_frame>Baseline up to end of treatment (approximately 1 year)</time_frame>
    <description>The nATA positive was defined as positive ATA with neutralizing activity at any postbaseline visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient-Reported Outcome (PRO) Scores by mPFS Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at EOT</measure>
    <time_frame>Baseline up to end of treatment (approximately 1 year)</time_frame>
    <description>EORTC QLQ-C30 included 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. It has 28 questions (4-point scale where 1=not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=very poor [worst] to 7= excellent [best]). Raw scores were converted into scale scores from 0 to 100. For functional scales and global health status/QOL scale, higher scores show better QOL; for symptom scales, lower scores show better QOL. mPFS was time from date of randomization to date of first of documentation of PD, death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for HL after completion of frontline therapy. PD is any new lesion or increase by &gt;=50% of previously involved sites from nadir.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1334</enrollment>
  <condition>Hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>A + AVD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A+AVD consists of brentuximab vedotin (ADCETRIS®) 1.2 milligram per kilogram (mg/kg) plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine (DTIC) 375 mg/m^2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABVD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ABVD consists of doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine (DTIC) 375 mg/m^2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>brentuximab vedotin</intervention_name>
    <description>Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
    <arm_group_label>A + AVD</arm_group_label>
    <other_name>ADCETRIS®</other_name>
    <other_name>SGN-35</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>doxorubicin</intervention_name>
    <description>Doxorubicin: 25 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
    <arm_group_label>A + AVD</arm_group_label>
    <arm_group_label>ABVD</arm_group_label>
    <other_name>Adriamycin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bleomycin</intervention_name>
    <description>Bleomycin: 10 units/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
    <arm_group_label>ABVD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>vinblastine</intervention_name>
    <description>Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle</description>
    <arm_group_label>A + AVD</arm_group_label>
    <arm_group_label>ABVD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dacarbazine</intervention_name>
    <description>Dacarbazine (DTIC): 375 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.</description>
    <arm_group_label>A + AVD</arm_group_label>
    <arm_group_label>ABVD</arm_group_label>
    <other_name>DTIC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Treatment-naïve participants with Ann Arbor Stage III or IV HL.&#xD;
&#xD;
          2. Histologically confirmed classical Hodgkin Lymphoma (HL) according to the current&#xD;
             World Health Organization (WHO) classification.&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to&#xD;
             (&lt;=) 2.&#xD;
&#xD;
          4. Bidimensional measurable disease as documented by radiographic technique per the&#xD;
             International Working Group Revised Criteria for Response Assessment for Malignant&#xD;
             Lymphoma.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Nodular lymphocyte predominant Hodgkin lymphoma.&#xD;
&#xD;
          2. Cerebral/meningeal disease, including signs and symptoms of progressive&#xD;
             multifocalleukoencephalopathy (PML).&#xD;
&#xD;
          3. Sensory or motor peripheral neuropathy.&#xD;
&#xD;
          4. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy&#xD;
             within 12 weeks of first study drug dose.&#xD;
&#xD;
          5. Known human immunodeficiency virus (HIV) positive.&#xD;
&#xD;
          6. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C&#xD;
             infection.&#xD;
&#xD;
        Please note that there are additional exclusion criteria. The study center will determine&#xD;
        if you meet all of the criteria.&#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>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Luis Obispo</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lonetree</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Niles</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zion</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Goshen</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fairway</city>
        <state>Kansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rockville Centre</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bismarck</city>
        <state>North Dakota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kennewick</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yakima</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kingswood</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St Leonards</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bedford Park</city>
        <state>South Australia</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hobart</city>
        <state>Tasmania</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>East Melbourne</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Geelong</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brugge</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salvador</city>
        <state>Bahia</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Curitiba</city>
        <state>Parana</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santo Andre</city>
        <state>Sao Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rio De Janeiro</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sao paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hradec Kralove</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Prague</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Praha 10</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aalborg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aarhus C</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Odense C</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roskilde</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Argenteuil</city>
        <state>Cedex</state>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Tronche</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lai Chi Kok</city>
        <state>Kowloon</state>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tuen Mun</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gyor</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pecs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szeged</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Modena</city>
        <state>Emilia-Romagna</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Alessandria</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cagliari</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cuneo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rionero In Volture</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rozzano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Torrette Di Ancona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Minami-ku</city>
        <state>Fukuoka-city</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Higashi-ku</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Minami-ku</city>
        <state>Hiroshima-city</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Showamachi</city>
        <state>Maebashi-city</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chikusa-ku</city>
        <state>Nagoya</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Suita</city>
        <state>Osaka Prefecture</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aoba-ku</city>
        <state>Sendai-city</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chuo-ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Isehara-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Koto-ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Goyang</city>
        <state>Gyeonggi</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hwasun-gun</city>
        <state>Jeollanam-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seocho-gu</city>
        <state>Seoul</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jeonju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gdansk</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>L0dz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Olsztyn</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint-Petersburg</city>
        <state>Poselok Pesochny</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ufa</city>
        <state>Republic Of Bashkortostan</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kazan</city>
        <state>Republic Tatrstan</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moskva</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St.Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Amanzimtoti</city>
        <state>Kwa Zulu Natal</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bloemfontein</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Badalona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marbella</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salamanca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santiago de Compostela</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Changhua City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chiayi County 613</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taoyuan County</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Samsun</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Truro</city>
        <state>Cornwall</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aberdeen</city>
        <state>Scotland</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glasgow</city>
        <state>Scotland</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sutton</city>
        <state>Surrey</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cardiff</city>
        <state>Wales</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Canterbury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Exeter</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Inverness</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leicester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lincoln</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norfolk</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Northwood</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Romford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <results_first_submitted>April 18, 2018</results_first_submitted>
  <results_first_submitted_qc>October 29, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 27, 2018</results_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hodgkin Lymphoma</keyword>
  <keyword>Hodgkins Lymphoma</keyword>
  <keyword>Antibody, Monoclonal</keyword>
  <keyword>Antibody-Drug Conjugate</keyword>
  <keyword>Antigens, CD-30</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>Lymphoma</keyword>
  <keyword>Lymphoma, Classical</keyword>
  <keyword>ECHELON-1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Hodgkin Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Bleomycin</mesh_term>
    <mesh_term>Dacarbazine</mesh_term>
    <mesh_term>Brentuximab Vedotin</mesh_term>
    <mesh_term>Vinblastine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </patient_data>
  <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>March 2, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT01712490/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>March 10, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT01712490/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 218 investigative sites in Asia Pacific, Europe, Latin America, and North America from 09 November 2012 to the primary completion date of 20 April 2017.</recruitment_details>
      <pre_assignment_details>Participants with histologically confirmed diagnosis of advanced classical hodgkin lymphoma (cHL) were enrolled to receive: brentuximab vedotin 1.2 mg/kg plus doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (A+AVD) or doxorubicin 25 mg/m^2, bleomycin 10 units/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (ABVD).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>A+AVD</title>
          <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
        </group>
        <group group_id="P2">
          <title>ABVD</title>
          <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="664"/>
                <participants group_id="P2" count="670"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="662"/>
                <participants group_id="P2" count="659"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="664"/>
                <participants group_id="P2" count="670"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Ongoing</title>
              <participants_list>
                <participants group_id="P1" count="601"/>
                <participants group_id="P2" count="586"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The intent-to-treat (ITT) population included all participants randomized to treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>A+AVD</title>
          <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
        </group>
        <group group_id="B2">
          <title>ABVD</title>
          <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</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="664"/>
            <count group_id="B2" value="670"/>
            <count group_id="B3" value="1334"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>The ITT population included all participants randomized to treatment.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.8" spread="15.83"/>
                    <measurement group_id="B2" value="40.2" spread="16.05"/>
                    <measurement group_id="B3" value="39.5" spread="15.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>The ITT population included all participants randomized to treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="286"/>
                    <measurement group_id="B2" value="272"/>
                    <measurement group_id="B3" value="558"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="378"/>
                    <measurement group_id="B2" value="398"/>
                    <measurement group_id="B3" value="776"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>The ITT population included all participants randomized to treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="106"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="571"/>
                    <measurement group_id="B2" value="577"/>
                    <measurement group_id="B3" value="1148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>The ITT population included all participants randomized to treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="560"/>
                    <measurement group_id="B2" value="554"/>
                    <measurement group_id="B3" value="1114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)</title>
        <description>mPFS was defined as the time from the date of randomization to the date of the first of documentation of progressive disease (PD), death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for Hodgkin lymphoma (HL) after completion of frontline therapy. PD was defined as any new lesion or increase by greater than or equal to (&gt;=) 50 percent (%) of previously involved sites from nadir. Frontline therapy is the part of standard set of treatments.</description>
        <time_frame>Baseline until PD or death or receipt of any subsequent anticancer therapy for HL after completion of frontline therapy (approximately up to 4 years)</time_frame>
        <population>The ITT population included all participants randomized to treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
          <group group_id="O2">
            <title>ABVD</title>
            <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)</title>
          <description>mPFS was defined as the time from the date of randomization to the date of the first of documentation of progressive disease (PD), death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for Hodgkin lymphoma (HL) after completion of frontline therapy. PD was defined as any new lesion or increase by greater than or equal to (&gt;=) 50 percent (%) of previously involved sites from nadir. Frontline therapy is the part of standard set of treatments.</description>
          <population>The ITT population included all participants randomized to treatment.</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="664"/>
                <count group_id="O2" value="670"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="48.2" upper_limit="NA">Median and confidence interval was not estimable due to low number of participants with events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and confidence interval was not estimable due to low number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hazard ratio (A+AVD/ABVD) and 95% confidence interval (CI) are based on a stratified Cox's proportional hazard regression model with stratification factors region and number of International Prognostic Factor Project (IPFP) risk factors at baseline with treatment as the explanatory variable in the model. Hazard ratio less than (&lt;) 1 favors A+AVD arm.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.035</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.770</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.603</ci_lower_limit>
            <ci_upper_limit>0.983</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis were censored at the date last known to be alive.</description>
        <time_frame>Baseline until death (approximately up to 4 years)</time_frame>
        <population>The ITT population included all participants randomized to treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
          <group group_id="O2">
            <title>ABVD</title>
            <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis were censored at the date last known to be alive.</description>
          <population>The ITT population included all participants randomized to treatment.</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="664"/>
                <count group_id="O2" value="670"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median and confidence interval was not estimable due to low number of participants with events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and confidence interval was not estimable due to low number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hazard ratio (A+AVD/ABVD) and 95% CI are based on a stratified Cox's proportional hazard regression model with stratification factors region and number of IPFP risk factors at baseline with treatment as the explanatory variable in the model. Hazard ratio &lt;1 favors A+AVD arm.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.199</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.728</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.448</ci_lower_limit>
            <ci_upper_limit>1.184</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF</title>
        <description>CR rate at the end of randomized regimen per investigator was defined as the percentage of participants who achieved CR at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by IRF. CR was defined as disappearance of all evidence of disease.</description>
        <time_frame>Baseline up to end of randomized regimen (approximately 1 year)</time_frame>
        <population>The ITT population included all participants randomized to treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
          <group group_id="O2">
            <title>ABVD</title>
            <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF</title>
          <description>CR rate at the end of randomized regimen per investigator was defined as the percentage of participants who achieved CR at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by IRF. CR was defined as disappearance of all evidence of disease.</description>
          <population>The ITT population included all participants randomized to treatment.</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="664"/>
                <count group_id="O2" value="670"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)</title>
        <time_frame>Baseline up to 30 days after last dose of study drug (approximately 1 year)</time_frame>
        <population>The safety population included all enrolled participants who received at least 1 dose of any study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
          <group group_id="O2">
            <title>ABVD</title>
            <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)</title>
          <population>The safety population included all enrolled participants who received at least 1 dose of any study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="662"/>
                <count group_id="O2" value="659"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="653"/>
                    <measurement group_id="O2" value="646"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="284"/>
                    <measurement group_id="O2" value="178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Clinical Laboratory Values</title>
        <time_frame>Baseline up to 30 days after last dose of study drug (approximately 1 year)</time_frame>
        <population>The safety population included all enrolled participants who received at least 1 dose of any study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
          <group group_id="O2">
            <title>ABVD</title>
            <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Clinical Laboratory Values</title>
          <population>The safety population included all enrolled participants who received at least 1 dose of any study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="662"/>
                <count group_id="O2" value="659"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="662"/>
                    <measurement group_id="O2" value="658"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Event-free Survival (EFS) Per IRF</title>
        <description>EFS was defined as the time from randomization until any cause of treatment failure: PD, premature discontinuation of randomized treatment for any reason, or death due to any cause, whichever occurs first. PD was defined as any new lesion or increase by &gt;=50% of previously involved sites from nadir per IRF.</description>
        <time_frame>Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years)</time_frame>
        <population>The ITT population included all participants randomized to treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
          <group group_id="O2">
            <title>ABVD</title>
            <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Event-free Survival (EFS) Per IRF</title>
          <description>EFS was defined as the time from randomization until any cause of treatment failure: PD, premature discontinuation of randomized treatment for any reason, or death due to any cause, whichever occurs first. PD was defined as any new lesion or increase by &gt;=50% of previously involved sites from nadir per IRF.</description>
          <population>The ITT population included all participants randomized to treatment.</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="664"/>
                <count group_id="O2" value="670"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="43.8" upper_limit="NA">Median and confidence interval was not estimable due to low number of participants with events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and confidence interval was not estimable due to low number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease-free Survival (DFS) Per IRF</title>
        <description>DFS per IRF was defined as the time from CR to disease progression as determined by an IRF or to death from lymphoma or acute toxicity from treatment. CR was defined as disappearance of all evidence of disease.</description>
        <time_frame>From CR until PD or death (approximately up to 4 years)</time_frame>
        <population>The ITT included all participants randomized to treatment. The ITT population where participants achieved CR.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
          <group group_id="O2">
            <title>ABVD</title>
            <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease-free Survival (DFS) Per IRF</title>
          <description>DFS per IRF was defined as the time from CR to disease progression as determined by an IRF or to death from lymphoma or acute toxicity from treatment. CR was defined as disappearance of all evidence of disease.</description>
          <population>The ITT included all participants randomized to treatment. The ITT population where participants achieved CR.</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="543"/>
                <count group_id="O2" value="528"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="42.1" upper_limit="NA">Median and confidence interval was not estimable due to low number of participants with events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and confidence interval was not estimable due to low number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (ORR) Per IRF</title>
        <description>ORR per IRF was defined as the percentage of participants who achieved CR or partial remission (PR) at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by an IRF. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.</description>
        <time_frame>Baseline up to end of randomized regimen (approximately 1 year)</time_frame>
        <population>The ITT population included all participants randomized to treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
          <group group_id="O2">
            <title>ABVD</title>
            <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (ORR) Per IRF</title>
          <description>ORR per IRF was defined as the percentage of participants who achieved CR or partial remission (PR) at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by an IRF. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.</description>
          <population>The ITT population included all participants randomized to treatment.</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="664"/>
                <count group_id="O2" value="670"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR) Per IRF</title>
        <description>DOR per IRF in participants with response was the time between first documentation of response (PR or CR) and PD as determined by an IRF. PD was defined as any new lesion or increase by &gt;=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.</description>
        <time_frame>From first documented response until PD (approximately 4 years)</time_frame>
        <population>The ITT population included all participants randomized to treatment. The ITT population where participants achieved confirmed response of CR or PR.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
          <group group_id="O2">
            <title>ABVD</title>
            <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR) Per IRF</title>
          <description>DOR per IRF in participants with response was the time between first documentation of response (PR or CR) and PD as determined by an IRF. PD was defined as any new lesion or increase by &gt;=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.</description>
          <population>The ITT population included all participants randomized to treatment. The ITT population where participants achieved confirmed response of CR or PR.</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="628"/>
                <count group_id="O2" value="623"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="42.1" upper_limit="NA">Median and confidence interval was not estimable due to low number of participants with events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and confidence interval was not estimable due to low number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Complete Remission (DOCR) Per IRF</title>
        <description>DOCR per IRF in participants with CR was the time between first documentation of CR and PD as determined by an IRF. PD was defined as any new lesion or increase by &gt;=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease.</description>
        <time_frame>From first documentation of CR until PD (approximately 4 years)</time_frame>
        <population>The ITT population included all participants randomized to treatment. The ITT population where participants achieved CR.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
          <group group_id="O2">
            <title>ABVD</title>
            <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Complete Remission (DOCR) Per IRF</title>
          <description>DOCR per IRF in participants with CR was the time between first documentation of CR and PD as determined by an IRF. PD was defined as any new lesion or increase by &gt;=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease.</description>
          <population>The ITT population included all participants randomized to treatment. The ITT population where participants achieved CR.</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="543"/>
                <count group_id="O2" value="528"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="42.1" upper_limit="NA">Median and confidence interval was not estimable due to low number of participants with events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and confidence interval was not estimable due to low number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Not in CR Per IRF Who Received Subsequent Radiation After Completion of Frontline Therapy</title>
        <description>CR was defined as disappearance of all evidence of disease as determined by an IRF.</description>
        <time_frame>Baseline up to end of frontline therapy (approximately 4 years)</time_frame>
        <population>The ITT population included all participants randomized to treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
          <group group_id="O2">
            <title>ABVD</title>
            <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Not in CR Per IRF Who Received Subsequent Radiation After Completion of Frontline Therapy</title>
          <description>CR was defined as disappearance of all evidence of disease as determined by an IRF.</description>
          <population>The ITT population included all participants randomized to treatment.</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="664"/>
                <count group_id="O2" value="670"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Remission (CR) Per IRF Rate at the End of Frontline Therapy</title>
        <description>CR rate at the end of frontline therapy per IRF was defined as the percentage of participants who achieved CR at the end of frontline therapy that is after completion of either randomized regimen or alternate frontline therapy as determined by an IRF. CR was defined as disappearance of all evidence of disease.</description>
        <time_frame>Baseline up to end of frontline therapy (approximately 4 years)</time_frame>
        <population>The ITT population included all participants randomized to treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
          <group group_id="O2">
            <title>ABVD</title>
            <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Remission (CR) Per IRF Rate at the End of Frontline Therapy</title>
          <description>CR rate at the end of frontline therapy per IRF was defined as the percentage of participants who achieved CR at the end of frontline therapy that is after completion of either randomized regimen or alternate frontline therapy as determined by an IRF. CR was defined as disappearance of all evidence of disease.</description>
          <population>The ITT population included all participants randomized to treatment.</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="664"/>
                <count group_id="O2" value="670"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positron Emission Tomography (PET) Negativity Rate Per IRF at Cycle 2</title>
        <description>PET negativity rate at Cycle 2 was defined as the percentage of participants with negative Cycle 2 PET results defined as Deauville score less than or equal to (&lt;=) 3 at Cycle 2. The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans.</description>
        <time_frame>Cycle 2 Day 25</time_frame>
        <population>The ITT population included all participants randomized to treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
          <group group_id="O2">
            <title>ABVD</title>
            <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Positron Emission Tomography (PET) Negativity Rate Per IRF at Cycle 2</title>
          <description>PET negativity rate at Cycle 2 was defined as the percentage of participants with negative Cycle 2 PET results defined as Deauville score less than or equal to (&lt;=) 3 at Cycle 2. The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans.</description>
          <population>The ITT population included all participants randomized to treatment.</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="664"/>
                <count group_id="O2" value="670"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>A+AVD: Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) and Total Antibody (TAb)</title>
        <time_frame>Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose</time_frame>
        <population>The pharmacokinetic (PK) population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The intensive PK (iPK) population was the subset of PK population. The iPK population where data at specified timepoints was available.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
        </group_list>
        <measure>
          <title>A+AVD: Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) and Total Antibody (TAb)</title>
          <population>The pharmacokinetic (PK) population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The intensive PK (iPK) population was the subset of PK population. The iPK population where data at specified timepoints was available.</population>
          <units>microgram per milliliter (microgm/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 1: ADC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.9" spread="6.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3 Day 1: ADC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.6" spread="6.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1 Day 1: TAb</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.6" spread="5.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3 Day 1: TAb</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.4" spread="6.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE)</title>
        <time_frame>Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose</time_frame>
        <population>The PK population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The iPK population was the subset of PK population. The iPK population where data at specified timepoints was available.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
        </group_list>
        <measure>
          <title>A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE)</title>
          <population>The PK population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The iPK population was the subset of PK population. The iPK population where data at specified timepoints was available.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.20" spread="2.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.36" spread="0.790"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb</title>
        <time_frame>Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose</time_frame>
        <population>The PK population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The iPK population was the subset of PK population. The iPK population where data at specified timepoints was available.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
        </group_list>
        <measure>
          <title>A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb</title>
          <population>The PK population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The iPK population was the subset of PK population. The iPK population where data at specified timepoints was available.</population>
          <units>day*microgram per milliliter (day*ug/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 1: ADC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.4" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1 Day 1: TAb</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.0" spread="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin MMAE</title>
        <time_frame>Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose</time_frame>
        <population>The PK population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The iPK population was the subset of PK population. The iPK population where data at specified timepoints was available.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
        </group_list>
        <measure>
          <title>A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin MMAE</title>
          <population>The PK population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The iPK population was the subset of PK population. The iPK population where data at specified timepoints was available.</population>
          <units>day*nanogram per milliliter (day*ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.3" spread="19.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>A+AVD: Number of Participants With Antitherapeutic Antibody (ATA) and Neutralizing Antitherapeutic Antibody (nATA) Positive for Brentuximab Vedotin</title>
        <description>The nATA positive was defined as positive ATA with neutralizing activity at any postbaseline visit.</description>
        <time_frame>Baseline up to end of treatment (approximately 1 year)</time_frame>
        <population>The safety population included all enrolled participants who received at least 1 dose of any study drug. The safety population-immunogenicity-evaluable participants where baseline and at least one postbaseline sample was available.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
        </group_list>
        <measure>
          <title>A+AVD: Number of Participants With Antitherapeutic Antibody (ATA) and Neutralizing Antitherapeutic Antibody (nATA) Positive for Brentuximab Vedotin</title>
          <description>The nATA positive was defined as positive ATA with neutralizing activity at any postbaseline visit.</description>
          <population>The safety population included all enrolled participants who received at least 1 dose of any study drug. The safety population-immunogenicity-evaluable participants where baseline and at least one postbaseline sample was available.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="632"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ATA positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>nATA positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient-Reported Outcome (PRO) Scores by mPFS Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at EOT</title>
        <description>EORTC QLQ-C30 included 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. It has 28 questions (4-point scale where 1=not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=very poor [worst] to 7= excellent [best]). Raw scores were converted into scale scores from 0 to 100. For functional scales and global health status/QOL scale, higher scores show better QOL; for symptom scales, lower scores show better QOL. mPFS was time from date of randomization to date of first of documentation of PD, death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for HL after completion of frontline therapy. PD is any new lesion or increase by &gt;=50% of previously involved sites from nadir.</description>
        <time_frame>Baseline up to end of treatment (approximately 1 year)</time_frame>
        <population>The ITT population included all participants randomized to treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>A+AVD</title>
            <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
          </group>
          <group group_id="O2">
            <title>ABVD</title>
            <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient-Reported Outcome (PRO) Scores by mPFS Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at EOT</title>
          <description>EORTC QLQ-C30 included 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. It has 28 questions (4-point scale where 1=not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=very poor [worst] to 7= excellent [best]). Raw scores were converted into scale scores from 0 to 100. For functional scales and global health status/QOL scale, higher scores show better QOL; for symptom scales, lower scores show better QOL. mPFS was time from date of randomization to date of first of documentation of PD, death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for HL after completion of frontline therapy. PD is any new lesion or increase by &gt;=50% of previously involved sites from nadir.</description>
          <population>The ITT population included all participants randomized to treatment.</population>
          <units>units on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="664"/>
                <count group_id="O2" value="670"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: With mPFS event</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="115"/>
                    <count group_id="O2" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.15" spread="16.527"/>
                    <measurement group_id="O2" value="76.68" spread="18.661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without mPFS event</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="533"/>
                    <count group_id="O2" value="508"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.85" spread="16.648"/>
                    <measurement group_id="O2" value="79.91" spread="16.218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at end of treatment: with mPFS event</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="112"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.68" spread="15.434"/>
                    <measurement group_id="O2" value="8.58" spread="17.848"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at end of treatment: without mPFS event</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="475"/>
                    <count group_id="O2" value="452"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.35" spread="17.417"/>
                    <measurement group_id="O2" value="6.08" spread="16.141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (approximately 1 year) for a serious adverse event after the last dose of study drug</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population included all enrolled participants who received at least 1 dose of any study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>A+AVD</title>
          <description>Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.</description>
        </group>
        <group group_id="E2">
          <title>ABVD</title>
          <description>Doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.0)</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="9" subjects_at_risk="662"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="284" subjects_at_risk="662"/>
                <counts group_id="E2" subjects_affected="178" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="151" subjects_affected="114" subjects_at_risk="662"/>
                <counts group_id="E2" events="52" subjects_affected="43" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="30" subjects_affected="19" subjects_at_risk="662"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="7" subjects_at_risk="662"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy mediastinal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Histiocytosis haematophagic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Microvascular coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Atrial thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Branchial cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Cushing's syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="662"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="662"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="662"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="662"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Neutropenic colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Ileus paralytic</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Anal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="55" subjects_affected="44" subjects_at_risk="662"/>
                <counts group_id="E2" events="32" subjects_affected="28" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Catheter site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Complication associated with device</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Device related thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Gallbladder obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Liver disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="19" subjects_affected="18" subjects_at_risk="662"/>
                <counts group_id="E2" events="18" subjects_affected="15" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="662"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Septic embolus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Lymph gland infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pelvic infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pharyngeal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Cellulitis orbital</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="662"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Enteritis infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pericoronitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Aspergillus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Genital infection female</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Vulvitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Fungal sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pneumonia fungal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Herpes virus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Ophthalmic herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Infected lymphocele</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Phlebitis infective</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Flavivirus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hepatitis B</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Moraxella infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Parainfluenzae virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pneumonia streptococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pseudomonas test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Staphylococcus test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="662"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="662"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neuroendocrine tumour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pituitary tumour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>T-cell lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Bile duct cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Gastrointestinal stromal tumour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Benign ovarian tumour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="662"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Polyneuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Autonomic neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Spinal cord ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Schizoaffective disorder bipolar type</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </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="3" subjects_affected="3" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Anuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Ureteric obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="662"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pulmonary thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pulmonary toxicity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Lung infiltration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Organising pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="662"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="662"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Stridor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hidradenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="662"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Jugular vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pelvic venous thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Peripheral artery thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Venous thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Brachiocephalic vein occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Superior vena cava syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="662"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Vena cava thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="662"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (19.0)</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="644" subjects_at_risk="662"/>
                <counts group_id="E2" subjects_affected="632" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1169" subjects_affected="374" subjects_at_risk="662"/>
                <counts group_id="E2" events="813" subjects_affected="291" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="237" subjects_affected="136" subjects_at_risk="662"/>
                <counts group_id="E2" events="97" subjects_affected="65" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="124" subjects_affected="42" subjects_at_risk="662"/>
                <counts group_id="E2" events="118" subjects_affected="37" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="673" subjects_affected="346" subjects_at_risk="662"/>
                <counts group_id="E2" events="735" subjects_affected="369" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="361" subjects_affected="273" subjects_at_risk="662"/>
                <counts group_id="E2" events="336" subjects_affected="239" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="342" subjects_affected="212" subjects_at_risk="662"/>
                <counts group_id="E2" events="284" subjects_affected="183" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="231" subjects_affected="176" subjects_at_risk="662"/>
                <counts group_id="E2" events="155" subjects_affected="121" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="182" subjects_affected="138" subjects_at_risk="662"/>
                <counts group_id="E2" events="135" subjects_affected="104" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="185" subjects_affected="135" subjects_at_risk="662"/>
                <counts group_id="E2" events="79" subjects_affected="65" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="100" subjects_affected="84" subjects_at_risk="662"/>
                <counts group_id="E2" events="93" subjects_affected="75" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="74" subjects_affected="64" subjects_at_risk="662"/>
                <counts group_id="E2" events="37" subjects_affected="34" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="36" subjects_affected="33" subjects_at_risk="662"/>
                <counts group_id="E2" events="49" subjects_affected="47" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="272" subjects_affected="209" subjects_at_risk="662"/>
                <counts group_id="E2" events="293" subjects_affected="211" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="224" subjects_affected="149" subjects_at_risk="662"/>
                <counts group_id="E2" events="191" subjects_affected="128" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="97" subjects_affected="65" subjects_at_risk="662"/>
                <counts group_id="E2" events="66" subjects_affected="42" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="52" subjects_affected="37" subjects_at_risk="662"/>
                <counts group_id="E2" events="51" subjects_affected="46" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="40" subjects_affected="37" subjects_at_risk="662"/>
                <counts group_id="E2" events="53" subjects_affected="45" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="76" subjects_affected="68" subjects_at_risk="662"/>
                <counts group_id="E2" events="75" subjects_affected="69" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="39" subjects_affected="28" subjects_at_risk="662"/>
                <counts group_id="E2" events="40" subjects_affected="35" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="168" subjects_affected="148" subjects_at_risk="662"/>
                <counts group_id="E2" events="46" subjects_affected="40" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="285" subjects_affected="86" subjects_at_risk="662"/>
                <counts group_id="E2" events="191" subjects_affected="78" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="92" subjects_affected="68" subjects_at_risk="662"/>
                <counts group_id="E2" events="28" subjects_affected="26" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="81" subjects_affected="46" subjects_at_risk="662"/>
                <counts group_id="E2" events="59" subjects_affected="34" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="58" subjects_affected="47" subjects_at_risk="662"/>
                <counts group_id="E2" events="21" subjects_affected="19" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="41" subjects_affected="34" subjects_at_risk="662"/>
                <counts group_id="E2" events="13" subjects_affected="10" subjects_at_risk="659"/>
              </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="156" subjects_affected="118" subjects_at_risk="662"/>
                <counts group_id="E2" events="106" subjects_affected="76" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="50" subjects_affected="45" subjects_at_risk="662"/>
                <counts group_id="E2" events="35" subjects_affected="24" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="44" subjects_affected="34" subjects_at_risk="662"/>
                <counts group_id="E2" events="18" subjects_affected="14" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="200" subjects_affected="125" subjects_at_risk="662"/>
                <counts group_id="E2" events="87" subjects_affected="66" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="113" subjects_affected="89" subjects_at_risk="662"/>
                <counts group_id="E2" events="98" subjects_affected="77" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="127" subjects_affected="80" subjects_at_risk="662"/>
                <counts group_id="E2" events="87" subjects_affected="70" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="108" subjects_affected="79" subjects_at_risk="662"/>
                <counts group_id="E2" events="93" subjects_affected="67" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="96" subjects_affected="82" subjects_at_risk="662"/>
                <counts group_id="E2" events="59" subjects_affected="49" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="48" subjects_affected="40" subjects_at_risk="662"/>
                <counts group_id="E2" events="34" subjects_affected="29" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="41" subjects_affected="36" subjects_at_risk="662"/>
                <counts group_id="E2" events="18" subjects_affected="17" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="298" subjects_affected="189" subjects_at_risk="662"/>
                <counts group_id="E2" events="149" subjects_affected="111" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="261" subjects_affected="174" subjects_at_risk="662"/>
                <counts group_id="E2" events="103" subjects_affected="85" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="124" subjects_affected="93" subjects_at_risk="662"/>
                <counts group_id="E2" events="117" subjects_affected="92" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="120" subjects_affected="84" subjects_at_risk="662"/>
                <counts group_id="E2" events="89" subjects_affected="73" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="74" subjects_affected="64" subjects_at_risk="662"/>
                <counts group_id="E2" events="65" subjects_affected="57" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="52" subjects_affected="48" subjects_at_risk="662"/>
                <counts group_id="E2" events="68" subjects_affected="48" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" events="50" subjects_affected="40" subjects_at_risk="662"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="659"/>
              </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="126" subjects_at_risk="662"/>
                <counts group_id="E2" events="89" subjects_affected="82" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="53" subjects_affected="50" subjects_at_risk="662"/>
                <counts group_id="E2" events="52" subjects_affected="49" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="36" subjects_affected="35" subjects_at_risk="662"/>
                <counts group_id="E2" events="27" subjects_affected="25" subjects_at_risk="659"/>
              </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="108" subjects_affected="97" subjects_at_risk="662"/>
                <counts group_id="E2" events="139" subjects_affected="122" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="97" subjects_affected="79" subjects_at_risk="662"/>
                <counts group_id="E2" events="136" subjects_affected="121" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="82" subjects_affected="72" subjects_at_risk="662"/>
                <counts group_id="E2" events="65" subjects_affected="55" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="41" subjects_affected="40" subjects_at_risk="662"/>
                <counts group_id="E2" events="31" subjects_affected="28" subjects_at_risk="659"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="194" subjects_affected="173" subjects_at_risk="662"/>
                <counts group_id="E2" events="165" subjects_affected="146" subjects_at_risk="659"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="60" subjects_affected="43" subjects_at_risk="662"/>
                <counts group_id="E2" events="33" subjects_affected="28" subjects_at_risk="659"/>
              </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>In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>trialdisclosures@takeda.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/NCT01712490
org study id: C25003
secondary id: 2011-005450-60
secondary id: U1111-1161-4937
secondary id: 12/LO/1950
secondary id: JapicCTI-142491
secondary id: REec-2013-0114
secondary id: 1025002760
secondary id: C25003CTID
nct id: NCT01712490
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of
      comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin
      (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated
      A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and
      dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)
time frame: Baseline until PD or death or receipt of any subsequent anticancer therapy for HL after completion of frontline therapy (approximately up to 4 years)
description: mPFS was defined as the time from the date of randomization to the date of the first of documentation of progressive disease (PD), death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for Hodgkin lymphoma (HL) after completion of frontline therapy. PD was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir. Frontline therapy is the part of standard set of treatments.
measure: Overall Survival (OS)
time frame: Baseline until death (approximately up to 4 years)
description: OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis were censored at the date last known to be alive.
measure: Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF
time frame: Baseline up to end of randomized regimen (approximately 1 year)
description: CR rate at the end of randomized regimen per investigator was defined as the percentage of participants who achieved CR at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by IRF. CR was defined as disappearance of all evidence of disease.
measure: Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
time frame: Baseline up to 30 days after last dose of study drug (approximately 1 year)
measure: Number of Participants With Abnormal Clinical Laboratory Values
time frame: Baseline up to 30 days after last dose of study drug (approximately 1 year)
measure: Event-free Survival (EFS) Per IRF
time frame: Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years)
description: EFS was defined as the time from randomization until any cause of treatment failure: PD, premature discontinuation of randomized treatment for any reason, or death due to any cause, whichever occurs first. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir per IRF.
measure: Disease-free Survival (DFS) Per IRF
time frame: From CR until PD or death (approximately up to 4 years)
description: DFS per IRF was defined as the time from CR to disease progression as determined by an IRF or to death from lymphoma or acute toxicity from treatment. CR was defined as disappearance of all evidence of disease.
measure: Overall Response Rate (ORR) Per IRF
time frame: Baseline up to end of randomized regimen (approximately 1 year)
description: ORR per IRF was defined as the percentage of participants who achieved CR or partial remission (PR) at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by an IRF. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
measure: Duration of Response (DOR) Per IRF
time frame: From first documented response until PD (approximately 4 years)
description: DOR per IRF in participants with response was the time between first documentation of response (PR or CR) and PD as determined by an IRF. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
measure: Duration of Complete Remission (DOCR) Per IRF
time frame: From first documentation of CR until PD (approximately 4 years)
description: DOCR per IRF in participants with CR was the time between first documentation of CR and PD as determined by an IRF. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease.
measure: Percentage of Participants Not in CR Per IRF Who Received Subsequent Radiation After Completion of Frontline Therapy
time frame: Baseline up to end of frontline therapy (approximately 4 years)
description: CR was defined as disappearance of all evidence of disease as determined by an IRF.
measure: Complete Remission (CR) Per IRF Rate at the End of Frontline Therapy
time frame: Baseline up to end of frontline therapy (approximately 4 years)
description: CR rate at the end of frontline therapy per IRF was defined as the percentage of participants who achieved CR at the end of frontline therapy that is after completion of either randomized regimen or alternate frontline therapy as determined by an IRF. CR was defined as disappearance of all evidence of disease.
measure: Positron Emission Tomography (PET) Negativity Rate Per IRF at Cycle 2
time frame: Cycle 2 Day 25
description: PET negativity rate at Cycle 2 was defined as the percentage of participants with negative Cycle 2 PET results defined as Deauville score less than or equal to (<=) 3 at Cycle 2. The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans.
measure: A+AVD: Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) and Total Antibody (TAb)
time frame: Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
measure: A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
time frame: Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
measure: A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb
time frame: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
measure: A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin MMAE
time frame: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
measure: A+AVD: Number of Participants With Antitherapeutic Antibody (ATA) and Neutralizing Antitherapeutic Antibody (nATA) Positive for Brentuximab Vedotin
time frame: Baseline up to end of treatment (approximately 1 year)
description: The nATA positive was defined as positive ATA with neutralizing activity at any postbaseline visit.
measure: Change From Baseline in Patient-Reported Outcome (PRO) Scores by mPFS Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at EOT
time frame: Baseline up to end of treatment (approximately 1 year)
description: EORTC QLQ-C30 included 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. It has 28 questions (4-point scale where 1=not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=very poor [worst] to 7= excellent [best]). Raw scores were converted into scale scores from 0 to 100. For functional scales and global health status/QOL scale, higher scores show better QOL; for symptom scales, lower scores show better QOL. mPFS was time from date of randomization to date of first of documentation of PD, death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for HL after completion of frontline therapy. PD is any new lesion or increase by >=50% of previously involved sites from nadir.
arm group label: A + AVD
arm group type: Experimental
description: A+AVD consists of brentuximab vedotin (ADCETRIS®) 1.2 milligram per kilogram (mg/kg) plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine (DTIC) 375 mg/m^2.
arm group label: ABVD
arm group type: Active Comparator
description: ABVD consists of doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine (DTIC) 375 mg/m^2.
intervention type: Drug
intervention name: brentuximab vedotin
description: Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle.
arm group label: A + AVD
other name: ADCETRIS®
other name: SGN-35
intervention type: Drug
intervention name: doxorubicin
description: Doxorubicin: 25 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
arm group label: A + AVD
arm group label: ABVD
other name: Adriamycin
intervention type: Drug
intervention name: bleomycin
description: Bleomycin: 10 units/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
arm group label: ABVD
intervention type: Drug
intervention name: vinblastine
description: Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
arm group label: A + AVD
arm group label: ABVD
intervention type: Drug
intervention name: dacarbazine
description: Dacarbazine (DTIC): 375 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
arm group label: A + AVD
arm group label: ABVD
other name: DTIC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Takeda
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country: Australia
country: Belgium
country: Brazil
country: Canada
country: Czechia
country: Denmark
country: France
country: Hong Kong
country: Hungary
country: Italy
country: Japan
country: Korea, Republic of
country: Norway
country: Poland
country: Russian Federation
country: South Africa
country: Spain
country: Taiwan
country: Turkey
country: United Kingdom
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Hodgkin Disease
mesh term: Doxorubicin
mesh term: Bleomycin
mesh term: Dacarbazine
mesh term: Brentuximab Vedotin
mesh term: Vinblastine
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 