<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/NCT01705977</url>
  </required_header>
  <id_info>
    <org_study_id>115467</org_study_id>
    <secondary_id>2011-005667-25</secondary_id>
    <secondary_id>HGS1006-C1113</secondary_id>
    <nct_id>NCT01705977</nct_id>
  </id_info>
  <brief_title>Belimumab Assessment of Safety in SLE</brief_title>
  <acronym>BASE</acronym>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to further enhance the existing knowledge regarding the side&#xD;
      effects of belimumab when given with other lupus medicines to adults with active systemic&#xD;
      lupus erythematosus (SLE). This study mainly focuses on collecting information on serious&#xD;
      events that are not that common or may only be seen with long-term treatment. These events&#xD;
      include death, serious infections and other infections of interest, cancers, serious mental&#xD;
      health problems, including depression and suicide, and serious infusion and hypersensitivity&#xD;
      reactions. This study is being done to help understand if treatment with belimumab increases&#xD;
      the risk for these types of events. This study will also see if patients receiving belimumab&#xD;
      with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study participants receive standard therapy for SLE in addition to receiving the study drug,&#xD;
      either placebo (no active medicine) or belimumab. The controlled period of the study is 52&#xD;
      weeks. The random assignment in this study is &quot;1 to 1&quot; which means that participants have an&#xD;
      equal chance of receiving belimumab or placebo. After completion of the 52-week study period,&#xD;
      participants will be contacted by phone annually for 4 more years to assess health status.&#xD;
&#xD;
      Following the 52-week controlled period, participants who wish to continue treatment with&#xD;
      belimumab may be able to do so by being prescribed commercially available belimumab. If&#xD;
      belimumab is not commercially available in the participant's country, the participant may be&#xD;
      able to receive belimumab under a separate continuation protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2012</start_date>
  <completion_date type="Actual">August 10, 2022</completion_date>
  <primary_completion_date type="Actual">July 30, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Deaths - On Treatment Period (Week 52)</measure>
    <time_frame>Up to Week 52 (On-treatment period)</time_frame>
    <description>Number of participants who died during on-treatment period (Week 52) is reported. The on-treatment period was defined as first dose to last dose + 28 days (or death). The As-Treated Population was defined as all participants who were randomized and received at least one dose of study agent,grouped according to the actual treatment administered for the majority (greater than [&gt;]50 percent [%]) of the time. The on-treatment period was the primary analysis period for safety analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)</measure>
    <time_frame>Up to Week 52 (On-treatment period)</time_frame>
    <description>A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), non-melanoma skin cancer (NMSC), malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using Columbia-Suicide Severity Rating Scale [C-SSRS]) and serious infusion and hypersensitivity reactions (SIHR) is reported. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death). The on-treatment period was the primary analysis period for safety analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)</measure>
    <time_frame>Up to Week 52 (On-treatment period)</time_frame>
    <description>An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death) and was the primary analysis period for safety analyses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Deaths Reported - On-study Period (Week 52)</measure>
    <time_frame>Up to Week 52 (On-study period)</time_frame>
    <description>Number of participants who died during on-study period (Week 52) is reported. The on-study period (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Reported Protocol Defined AESI: On-study Period (Week 52)</measure>
    <time_frame>Up to Week 52 (On-study period)</time_frame>
    <description>A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), NMSC, malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using C-SSRS) and SIHR is reported. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With SAEs Reported During On-study Period (Week 52)</measure>
    <time_frame>Up to Week 52 (On-study period)</time_frame>
    <description>A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death) and was a supportive analysis period for safety analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Whose Average Prednisone (or Equivalent) Dose to Treat SLE Has Been Reduced by &gt;=25% From Baseline to &lt;=7.5 mg/Day During Weeks 40 Through 52</measure>
    <time_frame>Week 40 to Week 52</time_frame>
    <description>The average daily prednisone dose during Weeks 40 to 52 is the sum of all prednisone doses to treat SLE from the day following the Week 40 visit date up to but not including the Week 52 study completion date divided by the number of days between Week 40 visit date and study completion date (study completion date - Week 40 visit date). Percentage of participants whose average prednisone dose has been reduced by &gt;=25% from Baseline to &lt;=7.5 mg/day during Weeks 40 through 52 in participants with average prednisone use greater than 7.5 mg/day at Baseline was compared between belimumab and placebo using a logistic regression model including treatment group, Baseline prednisone dose, screening safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score (&lt;=9 versus &gt;=10) and region. Baseline is defined as the last available value measured prior to dosing on or before the date of first dose (Day 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All-cause Mortality During Years 2 to 5</measure>
    <time_frame>From 2 years to 5 years</time_frame>
    <description>Number of participants with all-cause mortality during years 2 to 5 has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With New Primary Malignancies During Years 2 to 5</measure>
    <time_frame>From 2 years to 5 years</time_frame>
    <description>Number of participants with new primary malignancies during years 2 to 5 has been presented.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4019</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <arm_group>
    <arm_group_label>Placebo plus standard therapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Belimumab 10 mg/kg plus standard therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Belimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo plus standard therapy</intervention_name>
    <description>Placebo plus standard therapy</description>
    <arm_group_label>Placebo plus standard therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Belimumab 10 mg/kg plus standard therapy</intervention_name>
    <description>Belimumab 10 mg/kg plus standard therapy</description>
    <arm_group_label>Belimumab 10 mg/kg plus standard therapy</arm_group_label>
    <other_name>BENLYSTA™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard therapy</intervention_name>
    <description>Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; other biologics are not permitted.</description>
    <arm_group_label>Belimumab 10 mg/kg plus standard therapy</arm_group_label>
    <arm_group_label>Placebo plus standard therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.&#xD;
&#xD;
          -  Active SLE disease.&#xD;
&#xD;
          -  Autoantibody-positive.&#xD;
&#xD;
          -  On stable SLE treatment regimen which may include corticosteroids (for example,&#xD;
             prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants&#xD;
             (for example, azathioprine, methotrexate, mycophenolate).&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing.&#xD;
&#xD;
          -  Have received treatment with any of the following: belimumab, either as a marketed&#xD;
             product or as an investigational agent; any B cell targeted therapy (for example,&#xD;
             rituximab) in the past year; or any biological agent (for example, adalimumab,&#xD;
             etanercept, infliximab, or anakinra) in the past 90 days.&#xD;
&#xD;
          -  Have received a live vaccine within the past 30 days.&#xD;
&#xD;
          -  Have severe active lupus kidney disease.&#xD;
&#xD;
          -  Have severe active central nervous system (CNS) lupus.&#xD;
&#xD;
          -  Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or&#xD;
             hepatitis C.&#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>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <zip>36207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Covina</city>
        <state>California</state>
        <zip>91722</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92646</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>92020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Murrieta</city>
        <state>California</state>
        <zip>92563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Leandro</city>
        <state>California</state>
        <zip>94578</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cedar Rapids</city>
        <state>Iowa</state>
        <zip>52403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint Clair Shores</city>
        <state>Michigan</state>
        <zip>48081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>West Bloomfield</city>
        <state>Michigan</state>
        <zip>48322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kalispell</city>
        <state>Montana</state>
        <zip>59901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rock Hill</city>
        <state>South Carolina</state>
        <zip>29732</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Summerville</city>
        <state>South Carolina</state>
        <zip>29486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hixson</city>
        <state>Tennessee</state>
        <zip>37343-7908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cypress</city>
        <state>Texas</state>
        <zip>77429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>McKinney</city>
        <state>Texas</state>
        <zip>75071</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Arlington</city>
        <state>Virginia</state>
        <zip>22205-3606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Beckley</city>
        <state>West Virginia</state>
        <zip>25801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Clarksburg</city>
        <state>West Virginia</state>
        <zip>26301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Capital Federal</city>
        <state>Buenos Aires</state>
        <zip>1425</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autonoma Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>1035</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autonoma Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1425ASQ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>La Plata</city>
        <state>Buenos Aires</state>
        <zip>1900</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lanús</city>
        <state>Buenos Aires</state>
        <zip>B1824KAJ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mar del Plata</city>
        <state>Buenos Aires</state>
        <zip>7600</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zarate</city>
        <state>Buenos Aires</state>
        <zip>2800</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000BIF</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2002KDS</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Venado Tuerto</city>
        <state>Santa Fe</state>
        <zip>2600</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Miguel de Tucumán</city>
        <state>Tucumán</state>
        <zip>T4000BRD</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1046AAQ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1425AGC</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cordoba</city>
        <zip>5004</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mendoza</city>
        <zip>5500</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tucuman</city>
        <zip>T4000ICL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Garran</city>
        <state>Australian Capital Territory</state>
        <zip>2605</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2153</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cuiaba</city>
        <state>Mato Grosso</state>
        <zip>78.040-360</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30130-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Juiz de Fora</city>
        <state>Minas Gerais</state>
        <zip>36010-570</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Curitiba</city>
        <state>Paraná</state>
        <zip>80440-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90560-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Itajaí</city>
        <state>Santa Catarina</state>
        <zip>88301-220</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sao Jose do Rio Preto</city>
        <state>São Paulo</state>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sao Paulo</city>
        <state>São Paulo</state>
        <zip>01244-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Belo Horizonte, Minas Gerais</city>
        <zip>30150-221</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Campinas</city>
        <zip>13083-888</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Campo Grande</city>
        <zip>79080-190</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Goiania</city>
        <zip>74110-120</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lajeado</city>
        <zip>95900-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>22411-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salvador</city>
        <zip>40050-410</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>São Paulo</city>
        <zip>01323-020</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>São Paulo</city>
        <zip>04032-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Plovdiv</city>
        <zip>4000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ruse</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shumen</city>
        <zip>9700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1612</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6001</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Targovisthe</city>
        <zip>7700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Veliko Tarnovo</city>
        <zip>5000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6T 0G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vaughan</city>
        <state>Ontario</state>
        <zip>L4L 4Y7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>La Serena</city>
        <zip>68650</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santigo</city>
        <zip>7500010</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Armenia</city>
        <zip>55860</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barranquilla</city>
        <zip>080002</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bogota</city>
        <zip>110111</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bucaramanga</city>
        <zip>680005</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chia</city>
        <zip>250007</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Medellin</city>
        <zip>050018</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osijek</city>
        <zip>31000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rijeka</city>
        <zip>51000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Brno</city>
        <zip>65691</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Praha 2</city>
        <zip>128 50</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Praha 5</city>
        <zip>150 06</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zlin</city>
        <zip>760 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tallinn</city>
        <zip>10117</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shatin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Budapest</city>
        <zip>1023</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Budapest</city>
        <zip>1097</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Debrecen</city>
        <zip>4031</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zalaegerszeg</city>
        <zip>8900</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bandung</city>
        <zip>40161</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Denpasar</city>
        <zip>80114</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Malang</city>
        <zip>65111</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Palembang</city>
        <zip>30126</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Yogyakarta</city>
        <zip>55281</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00151</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Firenze</city>
        <state>Toscana</state>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Padova</city>
        <state>Veneto</state>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pisa</city>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Daegu</city>
        <zip>700-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Daejeon</city>
        <zip>301-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Daejeon</city>
        <zip>302-799</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gwangju</city>
        <zip>501-757</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Incheon</city>
        <zip>400-711</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jeonju-si</city>
        <zip>561-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>133-792</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>143-729</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Suwon-si</city>
        <zip>443-380</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Suwon</city>
        <zip>16247</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Klaipeda</city>
        <zip>LT-92288</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ipoh</city>
        <zip>30990</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kota Bahru</city>
        <zip>15586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kota Kinabalu</city>
        <zip>88586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>56000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kuala Terengganu</city>
        <zip>20400</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Selangor</city>
        <zip>68100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seremban, Negeri Sembilan</city>
        <zip>70300</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Torreon</city>
        <state>Coahuila</state>
        <zip>27000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cuautitlan Izcalli</city>
        <state>Estado De México</state>
        <zip>54769</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44158</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44690</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo León</state>
        <zip>64718</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Merida</city>
        <state>Yucatán</state>
        <zip>97130</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>D.F</city>
        <zip>6726</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Guadalajara</city>
        <zip>44620</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mexico</city>
        <zip>14000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mexico</city>
        <zip>7760</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Luis Potosí</city>
        <zip>78200</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Luis Potosí</city>
        <zip>78240</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Torreon</city>
        <zip>27000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Auckland</city>
        <zip>622</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wellington</city>
        <zip>6011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Arequipa</city>
        <zip>4017</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lima</city>
        <zip>01</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lima</city>
        <zip>11</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lima</city>
        <zip>15048</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lima</city>
        <zip>Lima 29</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lima</city>
        <zip>Lima 31</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lima</city>
        <zip>Lima 33</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lima</city>
        <zip>Lima 41</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Angeles City, Pampanga</city>
        <zip>2009</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cebu City</city>
        <zip>6000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Davao City</city>
        <zip>8000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Iloilo City</city>
        <zip>5000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Las Pinas</city>
        <zip>1740</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manila</city>
        <zip>1000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manila</city>
        <zip>1510</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Quezon City</city>
        <zip>1102</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Krakow</city>
        <zip>31-066</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Almada</city>
        <zip>2801-915</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lisboa</city>
        <zip>1050-034</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Porto</city>
        <zip>4200-319</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Viseu</city>
        <zip>3504-509</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bucharest</city>
        <zip>020125</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Galati</city>
        <zip>800578</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Targu Mures</city>
        <zip>540142</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barnaul</city>
        <zip>656045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kemerovo</city>
        <zip>650066</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kursk</city>
        <zip>305007</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>190068</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saratov</city>
        <zip>410053</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194044</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Belgrade</city>
        <zip>11080</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Krusevac</city>
        <zip>37000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Niska Banja</city>
        <zip>18205</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sabac</city>
        <zip>15000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Piestany</city>
        <zip>921 12</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>8035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bilbao</city>
        <zip>48013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Castellón</city>
        <zip>12004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cordoba</city>
        <zip>140044</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Getafe/Madrid</city>
        <zip>28905</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Granada</city>
        <zip>18012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Malaga</city>
        <zip>29009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seville</city>
        <zip>4110</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vilajoyosa</city>
        <zip>3570</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St. Gallen</city>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zuerich</city>
        <zip>8006</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chiayi County</city>
        <zip>613</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gueishan Township,Taoyuan County</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Taichung</city>
        <zip>402</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Taipei</city>
        <zip>106</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Taipei</city>
        <zip>11490</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Donetsk</city>
        <zip>83045</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Donetsk</city>
        <zip>83114</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kharkiv</city>
        <zip>61176</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kyiv</city>
        <zip>1601</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kyiv</city>
        <zip>4114</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lviv</city>
        <zip>79010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Odesa</city>
        <zip>65026</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Poltava</city>
        <zip>36011</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ternopil</city>
        <zip>46002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Uzhgorod</city>
        <zip>88018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Indonesia</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Lithuania</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>New Zealand</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Norway</country>
  </removed_countries>
  <reference>
    <citation>Sheikh S, Scheinberg MA, Wei CC, Tegzova D, Stohl W, Acayaba de Toledo R, Mucenic T, Abello M, Maksimowicz-McKinnon K, Abud Mendoza C, Navarra S, Garcia M, Garcia de la Torre I, Ordi Ros J, Nami A, Levy R, Bass D, Ross J, Punwaney R, Harris J, Pierce A, Thorneloe K, Ji B, Roth D. Mortality and adverse events of special interest in adult patients with active, auto-antibody-positive systemic lupus erythematosus receiving intravenous belimumab (BASE): a global, randomised, double-blind, placebo-controlled, multicentre Phase 4 trial. Lancet Rheumatol. 2020; DOI: 10.1016/S2665-9913(20)30355-6</citation>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>July 19, 2019</results_first_submitted>
  <results_first_submitted_qc>November 11, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 29, 2019</results_first_posted>
  <last_update_submitted>August 8, 2023</last_update_submitted>
  <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Antibodies</keyword>
  <keyword>Lupus</keyword>
  <keyword>SLE</keyword>
  <keyword>Systemic Lupus Erythematosus</keyword>
  <keyword>Autoimmune Disease</keyword>
  <keyword>Belimumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Belimumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study is available via the Clinical Study Data Request site.</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_time_frame>IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>https://clinicalstudydatarequest.com/Posting.aspx?ID=20766</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>November 25, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT01705977/Prot_002.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>September 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT01705977/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a global, multi-center, randomized, placebo-controlled double blind study that evaluated adverse events of special interest in adult participants with active, autoantibody-positive systemic lupus erythematosus (SLE) when treated with belimumab plus standard therapy versus participants who received placebo plus standard therapy for 1 year, followed by a Year 2-5 post-treatment follow-up period.</recruitment_details>
      <pre_assignment_details>A total of 4019 participants were randomized in this study. 4003 participants who received at least one dose of study treatment contributed to the Intent-to-Treat (ITT) Population.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
        </group>
        <group group_id="P2">
          <title>Belimumab 10 mg/kg</title>
          <description>Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period (Year 1)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2009">Randomized</participants>
                <participants group_id="P2" count="2010">Randomized</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Intent-to-Treat Population</title>
              <participants_list>
                <participants group_id="P1" count="2002"/>
                <participants group_id="P2" count="2001"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1729"/>
                <participants group_id="P2" count="1741"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="280"/>
                <participants group_id="P2" count="269"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
                <participants group_id="P2" count="128"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Site closure</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missing study conclusion form</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but not treated</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-up Period (Years 2 to 5)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1670">1670 participants from the Year 1 - treatment period entered in the Year 2 to 5 follow-up period</participants>
                <participants group_id="P2" count="1695">1695 participants from the Year 1 - treatment period entered in the Year 2 to 5 follow-up period</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1474"/>
                <participants group_id="P2" count="1514"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="196"/>
                <participants group_id="P2" count="181"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="89"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missing</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics were reported for ITT Population.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
        </group>
        <group group_id="B2">
          <title>Belimumab 10 mg/kg</title>
          <description>Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</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="2002"/>
            <count group_id="B2" value="2001"/>
            <count group_id="B3" value="4003"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.8" spread="12.74"/>
                    <measurement group_id="B2" value="40.4" spread="12.75"/>
                    <measurement group_id="B3" value="40.6" spread="12.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1853"/>
                    <measurement group_id="B2" value="1848"/>
                    <measurement group_id="B3" value="3701"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="149"/>
                    <measurement group_id="B2" value="153"/>
                    <measurement group_id="B3" value="302"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White/Caucasian-European Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1070"/>
                    <measurement group_id="B2" value="1080"/>
                    <measurement group_id="B3" value="2150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White/Caucasian-Arabic/North African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed White Race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian-East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="310"/>
                    <measurement group_id="B2" value="307"/>
                    <measurement group_id="B3" value="617"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian-South East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="172"/>
                    <measurement group_id="B2" value="168"/>
                    <measurement group_id="B3" value="340"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian-Central/South Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian-Japanese Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed Asian Race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American/African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="155"/>
                    <measurement group_id="B2" value="175"/>
                    <measurement group_id="B3" value="330"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alaskan Native or American Indian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="257"/>
                    <measurement group_id="B2" value="228"/>
                    <measurement group_id="B3" value="485"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Deaths - On Treatment Period (Week 52)</title>
        <description>Number of participants who died during on-treatment period (Week 52) is reported. The on-treatment period was defined as first dose to last dose + 28 days (or death). The As-Treated Population was defined as all participants who were randomized and received at least one dose of study agent,grouped according to the actual treatment administered for the majority (greater than [&gt;]50 percent [%]) of the time. The on-treatment period was the primary analysis period for safety analyses.</description>
        <time_frame>Up to Week 52 (On-treatment period)</time_frame>
        <population>As-Treated Population. One participant in placebo group who received belimumab &gt;50% of the time was reported in the belimumab group.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
          <group group_id="O2">
            <title>Belimumab 10 mg/kg</title>
            <description>Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Deaths - On Treatment Period (Week 52)</title>
          <description>Number of participants who died during on-treatment period (Week 52) is reported. The on-treatment period was defined as first dose to last dose + 28 days (or death). The As-Treated Population was defined as all participants who were randomized and received at least one dose of study agent,grouped according to the actual treatment administered for the majority (greater than [&gt;]50 percent [%]) of the time. The on-treatment period was the primary analysis period for safety analyses.</description>
          <population>As-Treated Population. One participant in placebo group who received belimumab &gt;50% of the time was reported in the belimumab group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2001"/>
                <count group_id="O2" value="2002"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>0.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.31</ci_lower_limit>
            <ci_upper_limit>0.51</ci_upper_limit>
            <estimate_desc>95% Confidence Interval was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)</title>
        <description>A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), non-melanoma skin cancer (NMSC), malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using Columbia-Suicide Severity Rating Scale [C-SSRS]) and serious infusion and hypersensitivity reactions (SIHR) is reported. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death). The on-treatment period was the primary analysis period for safety analyses.</description>
        <time_frame>Up to Week 52 (On-treatment period)</time_frame>
        <population>As-Treated Population. One participant in placebo group who received belimumab &gt;50% of the time was reported in the belimumab group. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
          <group group_id="O2">
            <title>Belimumab 10 mg/kg</title>
            <description>Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)</title>
          <description>A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), non-melanoma skin cancer (NMSC), malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using Columbia-Suicide Severity Rating Scale [C-SSRS]) and serious infusion and hypersensitivity reactions (SIHR) is reported. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death). The on-treatment period was the primary analysis period for safety analyses.</description>
          <population>As-Treated Population. One participant in placebo group who received belimumab &gt;50% of the time was reported in the belimumab group. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2001"/>
                <count group_id="O2" value="2002"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serious Infections, n=2001, 2002</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2001"/>
                    <count group_id="O2" value="2002"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Opportunistic Infections and Other Infections of Interest, n=2001, 2002</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2001"/>
                    <count group_id="O2" value="2002"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malignancies (Excluding NMSC), n=2001, 2002</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2001"/>
                    <count group_id="O2" value="2002"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NMSC, n=2001, 2002</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2001"/>
                    <count group_id="O2" value="2002"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychiatric Events Suggesting Serious Mood Disorders and Anxiety (Serious depression), n=2001, 2002</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2001"/>
                    <count group_id="O2" value="2002"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicidality (C-SSRS), n=1986, 1972</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1986"/>
                    <count group_id="O2" value="1972"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SIHR, n=2001, 2002</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2001"/>
                    <count group_id="O2" value="2002"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="8"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>-0.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.55</ci_lower_limit>
            <ci_upper_limit>0.85</ci_upper_limit>
            <estimate_desc>95% CI for serious infections was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>-0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.60</ci_lower_limit>
            <ci_upper_limit>0.20</ci_upper_limit>
            <estimate_desc>95% CI for opportunistic infections and other infections of interest (serious and non-serious) was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>0.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.31</ci_lower_limit>
            <ci_upper_limit>0.31</ci_upper_limit>
            <estimate_desc>95% CI for malignancies (excluding NMSC) was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.21</ci_lower_limit>
            <ci_upper_limit>0.31</ci_upper_limit>
            <estimate_desc>95% CI for NMSC was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>0.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.02</ci_lower_limit>
            <ci_upper_limit>0.58</ci_upper_limit>
            <estimate_desc>95% CI for psychiatric events suggesting serious mood disorders and anxiety (serious depression) was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>0.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.44</ci_lower_limit>
            <ci_upper_limit>0.96</ci_upper_limit>
            <estimate_desc>95% CI for suicidality (C-SSRS) was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>0.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.01</ci_lower_limit>
            <ci_upper_limit>0.61</ci_upper_limit>
            <estimate_desc>95% CI for SIHR was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)</title>
        <description>An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death) and was the primary analysis period for safety analyses.</description>
        <time_frame>Up to Week 52 (On-treatment period)</time_frame>
        <population>As-Treated Population. One participant in placebo group who received belimumab &gt;50% of the time was reported in the belimumab group.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
          <group group_id="O2">
            <title>Belimumab 10 mg/kg</title>
            <description>Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)</title>
          <description>An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death) and was the primary analysis period for safety analyses.</description>
          <population>As-Treated Population. One participant in placebo group who received belimumab &gt;50% of the time was reported in the belimumab group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2001"/>
                <count group_id="O2" value="2002"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="222"/>
                    <measurement group_id="O2" value="220"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Deaths Reported - On-study Period (Week 52)</title>
        <description>Number of participants who died during on-study period (Week 52) is reported. The on-study period (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.</description>
        <time_frame>Up to Week 52 (On-study period)</time_frame>
        <population>As-Treated Population. One participant in placebo group who received belimumab &gt;50% of the time was reported in the belimumab group.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
          <group group_id="O2">
            <title>Belimumab 10 mg/kg</title>
            <description>Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Deaths Reported - On-study Period (Week 52)</title>
          <description>Number of participants who died during on-study period (Week 52) is reported. The on-study period (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.</description>
          <population>As-Treated Population. One participant in placebo group who received belimumab &gt;50% of the time was reported in the belimumab group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2001"/>
                <count group_id="O2" value="2002"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="13"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>-0.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.03</ci_lower_limit>
            <ci_upper_limit>0.13</ci_upper_limit>
            <estimate_desc>95% CI was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Reported Protocol Defined AESI: On-study Period (Week 52)</title>
        <description>A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), NMSC, malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using C-SSRS) and SIHR is reported. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.</description>
        <time_frame>Up to Week 52 (On-study period)</time_frame>
        <population>As-Treated Population. One participant in placebo group who received belimumab &gt;50% of the time was reported in the belimumab group. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
          <group group_id="O2">
            <title>Belimumab 10 mg/kg</title>
            <description>Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Protocol Defined AESI: On-study Period (Week 52)</title>
          <description>A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), NMSC, malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using C-SSRS) and SIHR is reported. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.</description>
          <population>As-Treated Population. One participant in placebo group who received belimumab &gt;50% of the time was reported in the belimumab group. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2001"/>
                <count group_id="O2" value="2002"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serious Infections, n=2001, 2002</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2001"/>
                    <count group_id="O2" value="2002"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Opportunistic Infections and Other Infections of Interest, n=2001, 2002</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2001"/>
                    <count group_id="O2" value="2002"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malignancies (Excluding NMC), n=2001, 2002</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2001"/>
                    <count group_id="O2" value="2002"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NMSC, n=2001, 2002</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2001"/>
                    <count group_id="O2" value="2002"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychiatric Events Suggesting Serious Mood Disorders and Anxiety (Serious depression), n=2001, 2002</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2001"/>
                    <count group_id="O2" value="2002"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicidality (C-SSRS), n=1988, 1974</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1988"/>
                    <count group_id="O2" value="1974"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SIHR, n=2001, 2002</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2001"/>
                    <count group_id="O2" value="2002"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="8"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>-0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.02</ci_lower_limit>
            <ci_upper_limit>0.51</ci_upper_limit>
            <estimate_desc>95% CI for serious infections was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>-1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.96</ci_lower_limit>
            <ci_upper_limit>-0.04</ci_upper_limit>
            <estimate_desc>95% CI for opportunistic infections and other infections of interest (serious and non-serious) was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>-0.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.44</ci_lower_limit>
            <ci_upper_limit>0.24</ci_upper_limit>
            <estimate_desc>95% CI for malignancies (excluding NMSC) was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.21</ci_lower_limit>
            <ci_upper_limit>0.31</ci_upper_limit>
            <estimate_desc>95% CI for NMSC was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>0.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.02</ci_lower_limit>
            <ci_upper_limit>0.58</ci_upper_limit>
            <estimate_desc>95% CI for psychiatric events suggesting serious mood disorders and anxiety (serious depression) was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.42</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
            <estimate_desc>95% CI for suicidality (C-SSRS) was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in percentage versus placebo</param_type>
            <param_value>0.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.01</ci_lower_limit>
            <ci_upper_limit>0.61</ci_upper_limit>
            <estimate_desc>95% CI for SIHR was calculated using simple asymptotic Chi-Square (Pearson) method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With SAEs Reported During On-study Period (Week 52)</title>
        <description>A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death) and was a supportive analysis period for safety analyses.</description>
        <time_frame>Up to Week 52 (On-study period)</time_frame>
        <population>As-Treated Population. One participant in placebo group who received belimumab &gt;50% of the time was reported in the belimumab group.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
          <group group_id="O2">
            <title>Belimumab 10 mg/kg</title>
            <description>Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With SAEs Reported During On-study Period (Week 52)</title>
          <description>A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death) and was a supportive analysis period for safety analyses.</description>
          <population>As-Treated Population. One participant in placebo group who received belimumab &gt;50% of the time was reported in the belimumab group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2001"/>
                <count group_id="O2" value="2002"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="241"/>
                    <measurement group_id="O2" value="233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Whose Average Prednisone (or Equivalent) Dose to Treat SLE Has Been Reduced by &gt;=25% From Baseline to &lt;=7.5 mg/Day During Weeks 40 Through 52</title>
        <description>The average daily prednisone dose during Weeks 40 to 52 is the sum of all prednisone doses to treat SLE from the day following the Week 40 visit date up to but not including the Week 52 study completion date divided by the number of days between Week 40 visit date and study completion date (study completion date - Week 40 visit date). Percentage of participants whose average prednisone dose has been reduced by &gt;=25% from Baseline to &lt;=7.5 mg/day during Weeks 40 through 52 in participants with average prednisone use greater than 7.5 mg/day at Baseline was compared between belimumab and placebo using a logistic regression model including treatment group, Baseline prednisone dose, screening safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score (&lt;=9 versus &gt;=10) and region. Baseline is defined as the last available value measured prior to dosing on or before the date of first dose (Day 1).</description>
        <time_frame>Week 40 to Week 52</time_frame>
        <population>ITT Population. Only those participants with Baseline prednisone&gt;7.5 mg/day were analyzed. The ITT population is defined as all participants who were randomized and received at least one dose of study agent and the analysis was performed per the treatment that a participant was randomized to receive, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
          <group group_id="O2">
            <title>Belimumab 10 mg/kg</title>
            <description>Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Whose Average Prednisone (or Equivalent) Dose to Treat SLE Has Been Reduced by &gt;=25% From Baseline to &lt;=7.5 mg/Day During Weeks 40 Through 52</title>
          <description>The average daily prednisone dose during Weeks 40 to 52 is the sum of all prednisone doses to treat SLE from the day following the Week 40 visit date up to but not including the Week 52 study completion date divided by the number of days between Week 40 visit date and study completion date (study completion date - Week 40 visit date). Percentage of participants whose average prednisone dose has been reduced by &gt;=25% from Baseline to &lt;=7.5 mg/day during Weeks 40 through 52 in participants with average prednisone use greater than 7.5 mg/day at Baseline was compared between belimumab and placebo using a logistic regression model including treatment group, Baseline prednisone dose, screening safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score (&lt;=9 versus &gt;=10) and region. Baseline is defined as the last available value measured prior to dosing on or before the date of first dose (Day 1).</description>
          <population>ITT Population. Only those participants with Baseline prednisone&gt;7.5 mg/day were analyzed. The ITT population is defined as all participants who were randomized and received at least one dose of study agent and the analysis was performed per the treatment that a participant was randomized to receive, regardless of the actual treatment received.</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="990"/>
                <count group_id="O2" value="986"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.2"/>
                    <measurement group_id="O2" value="19.9"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0284</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds ratio versus placebo</param_type>
            <param_value>1.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.03</ci_lower_limit>
            <ci_upper_limit>1.65</ci_upper_limit>
            <estimate_desc>95% CI and P-value was calculated from a logistic regression model for the comparison between belimumab and placebo including treatment group, Baseline prednisone dose, screening SELENA SLEDAI score (&lt;=9 versus &gt;=10) and region</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All-cause Mortality During Years 2 to 5</title>
        <description>Number of participants with all-cause mortality during years 2 to 5 has been presented.</description>
        <time_frame>From 2 years to 5 years</time_frame>
        <population>As-Treated Any Year 2-5 Follow-up Population consisted of all participants in the As-Treated population who completed at least one post-treatment follow-up visit for Year 2 to 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
          <group group_id="O2">
            <title>Belimumab 10 mg/kg</title>
            <description>Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All-cause Mortality During Years 2 to 5</title>
          <description>Number of participants with all-cause mortality during years 2 to 5 has been presented.</description>
          <population>As-Treated Any Year 2-5 Follow-up Population consisted of all participants in the As-Treated population who completed at least one post-treatment follow-up visit for Year 2 to 5.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1670"/>
                <count group_id="O2" value="1695"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With New Primary Malignancies During Years 2 to 5</title>
        <description>Number of participants with new primary malignancies during years 2 to 5 has been presented.</description>
        <time_frame>From 2 years to 5 years</time_frame>
        <population>As-Treated Any Year 2-5 Follow-up Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
          <group group_id="O2">
            <title>Belimumab 10 mg/kg</title>
            <description>Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With New Primary Malignancies During Years 2 to 5</title>
          <description>Number of participants with new primary malignancies during years 2 to 5 has been presented.</description>
          <population>As-Treated Any Year 2-5 Follow-up Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1670"/>
                <count group_id="O2" value="1695"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AESIs and all SAEs were collected up to Week 52 (On-study period), all-cause mortality was collected up to end of study (up to 5 years)</time_frame>
      <desc>All-cause mortality, AESIs and SAEs are summarized for the As-Treated Population. Only AESIs and SAEs were collected up to Week 52, but not all AEs. All-cause mortality was collected up to end of study (up to 5 years). One participant in placebo group who received belimumab &gt;50% of the time was reported in the belimumab group</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
        </group>
        <group group_id="E2">
          <title>Belimumab 10 mg/kg</title>
          <description>Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="80" subjects_at_risk="2001"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="241" subjects_at_risk="2001"/>
                <counts group_id="E2" subjects_affected="233" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2001"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Autoimmune haemolytic anaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Anaemia of chronic disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Antiphospholipid syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Aplastic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Haemolytic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Microangiopathic haemolytic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Thrombotic thrombocytopenic purpura</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Bundle branch block left</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Congestive cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Mitral valve disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Supraventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Anomalous pulmonary venous connection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Eyelid ptosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Periorbital swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Gastric disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Strangulated umbilical hernia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Epiploic appendagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Lupus enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Obstructive pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pancreatitis relapsing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Peptic ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Oedema due to renal disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Serositis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Autoimmune hepatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Hepatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Jaundice extrahepatic obstructive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Liver disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Anaphylactic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Allergy to arthropod sting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="28" subjects_affected="27" subjects_at_risk="2001"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="2001"/>
                <counts group_id="E2" events="17" subjects_affected="16" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="2001"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2001"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="2001"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2001"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Diarrhoea infectious</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Dengue haemorrhagic fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pelvic inflammatory disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Superinfection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Abdominal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Bartholinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Bursitis infective</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Chikungunya virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Complicated appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus mucocutaneous ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Endocarditis staphylococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Enterocolitis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>H1N1 influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Hookworm infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Intestinal sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Joint abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Joint tuberculosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Lip infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Lung abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Meningitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Meningitis listeria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Necrotising fasciitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Oesophageal candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Ophthalmic herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Oral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Parotitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pneumonia pseudomonal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Progressive multifocal leukoencephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Retroperitoneal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Staphylococcal skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Subdiaphragmatic abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Tuberculosis gastrointestinal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Tubo-ovarian abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Viral diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Sternal fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Brain contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Gun shot wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Ligament injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Postoperative respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Skull fractured base</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Subdural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Systemic lupus erythematosus</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="2001"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>SLE arthritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Osteoporotic fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Polyarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Anogenital warts</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Benign neoplasm of adrenal gland</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Brain neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cervix carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Diffuse large B-cell lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Enchondromatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Intraductal proliferative breast lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Mucoepidermoid carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Ovarian adenoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Renal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Thyroid adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Thyroid cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Central nervous system vasculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Carotid artery aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Central nervous system lupus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cervical radiculopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Generalised tonic-clonic seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Intracranial venous sinus thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Intraventricular haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Myelitis transverse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Neuropsychiatric lupus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Thalamus haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Abortion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Abortion threatened</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Foetal death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pre-eclampsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device breakage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Device leakage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Intentional self-injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Conversion disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Depression suicidal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Lupus nephritis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2001"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Nephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Nephrotic syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Prerenal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cervical dysplasia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Endometriosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Dysfunctional uterine bleeding</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Adenomyosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Haemorrhagic ovarian cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Ovarian adhesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Ovulation pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </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="7" subjects_affected="7" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Lupus pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Lupus pleurisy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pulmonary alveolar haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pulmonary artery thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Pulmonary infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Shrinking lung syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Cutaneous lupus erythematosus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Systemic lupus erythematosus rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Cutaneous vasculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Dermatomyositis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Dyshidrotic eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Erythema multiforme</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Stevens-Johnson syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Vasculitic ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Lupus vasculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Jugular vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Peripheral artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2001"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Raynaud's phenomenon</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Vasculitis necrotising</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Venous thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2001"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="2001"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="2002"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="33" subjects_affected="31" subjects_at_risk="2001"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="2002"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.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/NCT01705977
org study id: 115467
secondary id: 2011-005667-25
secondary id: HGS1006-C1113
nct id: NCT01705977
lead sponsor: 
has dmc: Yes
The purpose of this study is to further enhance the existing knowledge regarding the side
      effects of belimumab when given with other lupus medicines to adults with active systemic
      lupus erythematosus (SLE). This study mainly focuses on collecting information on serious
      events that are not that common or may only be seen with long-term treatment. These events
      include death, serious infections and other infections of interest, cancers, serious mental
      health problems, including depression and suicide, and serious infusion and hypersensitivity
      reactions. This study is being done to help understand if treatment with belimumab increases
      the risk for these types of events. This study will also see if patients receiving belimumab
      with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.
Study participants receive standard therapy for SLE in addition to receiving the study drug,
      either placebo (no active medicine) or belimumab. The controlled period of the study is 52
      weeks. The random assignment in this study is "1 to 1" which means that participants have an
      equal chance of receiving belimumab or placebo. After completion of the 52-week study period,
      participants will be contacted by phone annually for 4 more years to assess health status.

      Following the 52-week controlled period, participants who wish to continue treatment with
      belimumab may be able to do so by being prescribed commercially available belimumab. If
      belimumab is not commercially available in the participant's country, the participant may be
      able to receive belimumab under a separate continuation protocol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Deaths - On Treatment Period (Week 52)
time frame: Up to Week 52 (On-treatment period)
description: Number of participants who died during on-treatment period (Week 52) is reported. The on-treatment period was defined as first dose to last dose + 28 days (or death). The As-Treated Population was defined as all participants who were randomized and received at least one dose of study agent,grouped according to the actual treatment administered for the majority (greater than [>]50 percent [%]) of the time. The on-treatment period was the primary analysis period for safety analyses.
measure: Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)
time frame: Up to Week 52 (On-treatment period)
description: A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), non-melanoma skin cancer (NMSC), malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using Columbia-Suicide Severity Rating Scale [C-SSRS]) and serious infusion and hypersensitivity reactions (SIHR) is reported. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death). The on-treatment period was the primary analysis period for safety analyses.
measure: Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)
time frame: Up to Week 52 (On-treatment period)
description: An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death) and was the primary analysis period for safety analyses.
measure: Number of Deaths Reported - On-study Period (Week 52)
time frame: Up to Week 52 (On-study period)
description: Number of participants who died during on-study period (Week 52) is reported. The on-study period (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.
measure: Number of Participants Who Reported Protocol Defined AESI: On-study Period (Week 52)
time frame: Up to Week 52 (On-study period)
description: A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), NMSC, malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using C-SSRS) and SIHR is reported. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.
measure: Number of Participants With SAEs Reported During On-study Period (Week 52)
time frame: Up to Week 52 (On-study period)
description: A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death) and was a supportive analysis period for safety analyses.
measure: Percentage of Participants Whose Average Prednisone (or Equivalent) Dose to Treat SLE Has Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52
time frame: Week 40 to Week 52
description: The average daily prednisone dose during Weeks 40 to 52 is the sum of all prednisone doses to treat SLE from the day following the Week 40 visit date up to but not including the Week 52 study completion date divided by the number of days between Week 40 visit date and study completion date (study completion date - Week 40 visit date). Percentage of participants whose average prednisone dose has been reduced by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52 in participants with average prednisone use greater than 7.5 mg/day at Baseline was compared between belimumab and placebo using a logistic regression model including treatment group, Baseline prednisone dose, screening safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score (<=9 versus >=10) and region. Baseline is defined as the last available value measured prior to dosing on or before the date of first dose (Day 1).
measure: Number of Participants With All-cause Mortality During Years 2 to 5
time frame: From 2 years to 5 years
description: Number of participants with all-cause mortality during years 2 to 5 has been presented.
measure: Number of Participants With New Primary Malignancies During Years 2 to 5
time frame: From 2 years to 5 years
description: Number of participants with new primary malignancies during years 2 to 5 has been presented.
arm group label: Placebo plus standard therapy
arm group type: Placebo Comparator
description: Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period.
arm group label: Belimumab 10 mg/kg plus standard therapy
arm group type: Experimental
description: Belimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period.
intervention type: Biological
intervention name: Placebo plus standard therapy
description: Placebo plus standard therapy
arm group label: Placebo plus standard therapy
intervention type: Biological
intervention name: Belimumab 10 mg/kg plus standard therapy
description: Belimumab 10 mg/kg plus standard therapy
arm group label: Belimumab 10 mg/kg plus standard therapy
other name: BENLYSTA™
intervention type: Other
intervention name: Standard therapy
description: Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; other biologics are not permitted.
arm group label: Belimumab 10 mg/kg plus standard therapy
arm group label: Placebo plus standard therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Argentina
country: Australia
country: Brazil
country: Bulgaria
country: Canada
country: Chile
country: Colombia
country: Croatia
country: Czechia
country: Estonia
country: Hong Kong
country: Hungary
country: Indonesia
country: Italy
country: Korea, Republic of
country: Lithuania
country: Malaysia
country: Mexico
country: New Zealand
country: Peru
country: Philippines
country: Poland
country: Portugal
country: Romania
country: Russian Federation
country: Serbia
country: Slovakia
country: Spain
country: Switzerland
country: Taiwan
country: Thailand
country: Ukraine
country: United States
country: Czech Republic
country: Norway
citation: Sheikh S, Scheinberg MA, Wei CC, Tegzova D, Stohl W, Acayaba de Toledo R, Mucenic T, Abello M, Maksimowicz-McKinnon K, Abud Mendoza C, Navarra S, Garcia M, Garcia de la Torre I, Ordi Ros J, Nami A, Levy R, Bass D, Ross J, Punwaney R, Harris J, Pierce A, Thorneloe K, Ji B, Roth D. Mortality and adverse events of special interest in adult patients with active, auto-antibody-positive systemic lupus erythematosus receiving intravenous belimumab (BASE): a global, randomised, double-blind, placebo-controlled, multicentre Phase 4 trial. Lancet Rheumatol. 2020; DOI: 10.1016/S2665-9913(20)30355-6
responsible party type: Sponsor
mesh term: Lupus Erythematosus, Systemic
mesh term: Belimumab
sharing ipd: Yes
ipd description: IPD for this study is available via the Clinical Study Data Request site.
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 time frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: https://clinicalstudydatarequest.com/Posting.aspx?ID=20766
provided document: 
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reported events: 
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