<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/NCT01673867</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-057</org_study_id>
    <secondary_id>2012-002472-14</secondary_id>
    <nct_id>NCT01673867</nct_id>
  </id_info>
  <brief_title>Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC</brief_title>
  <acronym>CheckMate057</acronym>
  <official_title>An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as&#xD;
      compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC)&#xD;
      after failure of prior platinum-based chemotherapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2012</start_date>
  <completion_date type="Actual">December 17, 2021</completion_date>
  <primary_completion_date type="Actual">February 5, 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint</measure>
    <time_frame>Randomization until 413 deaths, up to March 2015 (approximately 29 months)</time_frame>
    <description>Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>From randomization to date of objectively documented progression (up to approximately 110 months)</time_frame>
    <description>ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time To Objective Response (TTOR)</measure>
    <time_frame>From randomization to the date of first confirmed response (up to approximately 110 months)</time_frame>
    <description>Time to Objective Response for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Objective Response (DOOR)</measure>
    <time_frame>From randomization to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)</time_frame>
    <description>DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment. Median computed using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>From randomization to first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)</time_frame>
    <description>PFS was defined as the time from randomization to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Progression will be assessed every 6 weeks (from the first on-study radiographic assessment) until disease progression is noted. Progressive disease was defined as least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Median computed using the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12</measure>
    <time_frame>Randomization to Week 12</time_frame>
    <description>Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) by PD-L1 Expression at Baseline</measure>
    <time_frame>From randomization to the date of death or last known date alive (up to approximately 110 months)</time_frame>
    <description>Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. Median computed using the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) by PD-L1 Expression at Baseline</measure>
    <time_frame>From randomization to date of objectively documented progression (up to approximately 110 months)</time_frame>
    <description>ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method. ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">582</enrollment>
  <condition>Non-Squamous Cell Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A: Nivolumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: Docetaxel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Docetaxel 75 mg/m^2 concentrate for solution for intravenous infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <arm_group_label>Arm A: Nivolumab</arm_group_label>
    <other_name>BMS-936558 (Anti-PD1)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <arm_group_label>Arm B: Docetaxel</arm_group_label>
    <other_name>Taxotere®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men &amp; women ≥18 years of age&#xD;
&#xD;
          -  Subjects with histologically or cytologically-documented non-squamous cell NSCLC who&#xD;
             present with Stage IIIB/IV disease or recurrent or progressive disease following&#xD;
             multimodal therapy (radiation therapy, surgical resection, or definitive&#xD;
             chemoradiation therapy for locally advanced disease) and who will receive study&#xD;
             therapy as second or third line of treatment for advanced disease&#xD;
&#xD;
          -  Disease recurrence or progression during/after one prior platinum doublet-based&#xD;
             chemotherapy regimen for advanced or metastatic disease&#xD;
&#xD;
          -  Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per&#xD;
             RECIST 1.1 criteria&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤1&#xD;
&#xD;
          -  A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of&#xD;
             tumor sample (archival or recent) must be available for biomarker evaluation.&#xD;
             Specimens must be received by the central lab prior to randomization. Biopsy should be&#xD;
             excisional, incisional or core needle. Fine needle aspiration is insufficient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects&#xD;
             are eligible if CNS metastases are asymptomatic or treated and subjects are&#xD;
             neurologically returned to baseline for at least 2 weeks prior to enrollment. In&#xD;
             addition, subjects must be either off corticosteroids, or on a stable or decreasing&#xD;
             dose of ≤10mg daily prednisone (or equivalent)&#xD;
&#xD;
          -  Subjects with carcinomatous meningitis&#xD;
&#xD;
          -  Subjects with active or recent history of known or suspected autoimmune disease.&#xD;
             Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone&#xD;
             replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring&#xD;
             systemic treatment are permitted to enroll&#xD;
&#xD;
          -  Subjects with a condition requiring systemic treatment with either corticosteroids or&#xD;
             other immunosuppressive medications within 14 days of randomization&#xD;
&#xD;
          -  Prior therapy with anti-programmed death-1 (anti-PD-1), anti-programmed cell death&#xD;
             ligand 1 (anti-PD-L1), anti-programmed cell death ligand 2 (anti-PD-L2), anti-cluster&#xD;
             of differentiation 137 (anti-CD137), or anti-Cytotoxic T lymphocyte-associated antigen&#xD;
             4 (anti-CTLA-4) antibody (including Ipilimumab or any other antibody or drug&#xD;
             specifically targeting T-cell co-stimulation or checkpoint pathways)&#xD;
&#xD;
          -  Prior treatment with Docetaxel&#xD;
&#xD;
          -  Treatment with any investigational agent within 14 days of first administration of&#xD;
             study treatment&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply&#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>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0009</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0042</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Francisco Oncology Associates</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0034</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Georgia Oncology Center, P.C.</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0030</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0031</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0040</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0138</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0008</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0020</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0027</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Local Institution - 0026</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>St. Mary Medical Center</name>
      <address>
        <city>Langhorne</city>
        <state>Pennsylvania</state>
        <zip>19047</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution - 0035</name>
      <address>
        <city>Sayre</city>
        <state>Pennsylvania</state>
        <zip>18840</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Local Institution - 0025</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0024</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0028</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution - 0033</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Local Institution - 0032</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution - 0041</name>
      <address>
        <city>Kennewick</city>
        <state>Washington</state>
        <zip>99336</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Cancer Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution - 0007</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Local Institution - 0019</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506-9162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0010</name>
      <address>
        <city>Capital Federal</city>
        <state>Buenos Aires</state>
        <zip>1426</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0057</name>
      <address>
        <city>Capital Federal</city>
        <state>Buenos Aires</state>
        <zip>1431</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0124</name>
      <address>
        <city>Ciudad De Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1181ACH</zip>
        <country>Argentina</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0011</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1280AEB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0125</name>
      <address>
        <city>La Rioja</city>
        <zip>5300</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tweed Heads</city>
        <state>New South Wales</state>
        <zip>2485</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kurralta Park</city>
        <state>South Australia</state>
        <zip>5037</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Frankston</city>
        <state>Victoria</state>
        <zip>3199</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Vienna</city>
        <zip>1130</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Wels</city>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0054</name>
      <address>
        <city>Salvador</city>
        <state>Bahia</state>
        <zip>40170-110</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0056</name>
      <address>
        <city>Fortaleza</city>
        <state>Ceara</state>
        <zip>60336550</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0053</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90020-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0055</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0052</name>
      <address>
        <city>Barretos</city>
        <state>Sao Paulo</state>
        <zip>14784-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0051</name>
      <address>
        <city>Rio De Janeiro</city>
        <zip>20231-050</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0133</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0110</name>
      <address>
        <city>Rimouski</city>
        <state>Quebec</state>
        <zip>G5L 5T1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0058</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <zip>7600448</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0077</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <zip>8420383</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0134</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0012</name>
      <address>
        <city>Viña Del Mar</city>
        <state>Valparaiso</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0018</name>
      <address>
        <city>Praha 8</city>
        <zip>180 81</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Creteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Dijon Cedex</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0119</name>
      <address>
        <city>La Roche Sur Yon Cedex 9</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0113</name>
      <address>
        <city>Lyon Cedex 08</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0112</name>
      <address>
        <city>Marseille Cedex 20</city>
        <zip>13915</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0114</name>
      <address>
        <city>Rennes Cedex 9</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Toulouse</city>
        <zip>31300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bad Berka</city>
        <zip>99437</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Grosshansdorf</city>
        <zip>22927</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Heidelberg</city>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0090</name>
      <address>
        <city>Koeln</city>
        <zip>51109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Recklinghausen</city>
        <zip>45657</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Stuttgart</city>
        <zip>70376</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0043</name>
      <address>
        <city>Hong Kong</city>
        <zip>0</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0074</name>
      <address>
        <city>Budapest</city>
        <zip>H-1121</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0122</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0086</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0087</name>
      <address>
        <city>Meldola (fc)</city>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0085</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0084</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0121</name>
      <address>
        <city>Parma</city>
        <zip>43100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0083</name>
      <address>
        <city>Perugia</city>
        <zip>06132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0088</name>
      <address>
        <city>Ravenna</city>
        <zip>48121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0082</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0107</name>
      <address>
        <city>Mexico</city>
        <state>Distrito Federal</state>
        <zip>06735</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0108</name>
      <address>
        <city>Mexico</city>
        <state>Distrito Federal</state>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64060</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Hermosillo</city>
        <state>Sonora</state>
        <zip>83280</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0141</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0131</name>
      <address>
        <city>Miraflores</city>
        <state>Lima</state>
        <zip>18</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0050</name>
      <address>
        <city>Arequipa</city>
        <zip>54</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0048</name>
      <address>
        <city>Lima</city>
        <zip>34</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0049</name>
      <address>
        <city>Lima</city>
        <zip>L-27</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0073</name>
      <address>
        <city>Krakow</city>
        <state>Małopolskie</state>
        <zip>30-002</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0068</name>
      <address>
        <city>Gdansk</city>
        <zip>80-19</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0072</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-513</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0067</name>
      <address>
        <city>Szczecin</city>
        <zip>70891</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0070</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0099</name>
      <address>
        <city>Bucuresti</city>
        <zip>010976</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0123</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400352</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0063</name>
      <address>
        <city>Craiova</city>
        <zip>200385</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0061</name>
      <address>
        <city>Iasi</city>
        <zip>700106</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0062</name>
      <address>
        <city>Timisoara</city>
        <zip>300167</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0078</name>
      <address>
        <city>Moscow</city>
        <zip>115 478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0079</name>
      <address>
        <city>Moscow</city>
        <zip>115 478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0120</name>
      <address>
        <city>Moscow</city>
        <zip>115 478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0080</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Singapore</city>
        <zip>169610</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Singapore</city>
        <zip>308433</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0001</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Vizcaya</city>
        <zip>48903</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Chur</city>
        <zip>7000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>Norway</country>
    <country>Peru</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>South Africa</country>
    <country>Turkey</country>
  </removed_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>Investigator Inquiry Form</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <results_first_submitted>January 29, 2016</results_first_submitted>
  <results_first_submitted_qc>January 29, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 26, 2016</results_first_posted>
  <last_update_submitted>January 13, 2023</last_update_submitted>
  <last_update_submitted_qc>January 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Nivolumab</title>
          <description>Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
        </group>
        <group group_id="P2">
          <title>Docetaxel</title>
          <description>Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Randomization</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="292"/>
                <participants group_id="P2" count="290"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="287"/>
                <participants group_id="P2" count="268"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse event unrelated to study drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant request to discontinue study treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by participant</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant no longer meets study criteria</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="287"/>
                <participants group_id="P2" count="268"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Who Transitioned to Nivolumab 3 mg/kg</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Who Transitioned to Nivolumab 480 mg</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="285"/>
                <participants group_id="P2" count="268"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="208"/>
                <participants group_id="P2" count="178"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Drug Toxicity</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse event unrelated to study drug</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant request to discontinue study treatment</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by participant</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Maximum clinical benefit</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant no longer meets study criteria</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Administrative reason by sponsor</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reason</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants</population>
      <group_list>
        <group group_id="B1">
          <title>Nivolumab</title>
          <description>Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
        </group>
        <group group_id="B2">
          <title>Docetaxel</title>
          <description>Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</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="292"/>
            <count group_id="B2" value="290"/>
            <count group_id="B3" value="582"/>
          </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="60.9" spread="9.27"/>
                    <measurement group_id="B2" value="62.3" spread="9.75"/>
                    <measurement group_id="B3" value="61.6" spread="9.53"/>
                  </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="141"/>
                    <measurement group_id="B2" value="122"/>
                    <measurement group_id="B3" value="263"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="151"/>
                    <measurement group_id="B2" value="168"/>
                    <measurement group_id="B3" value="319"/>
                  </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>American Indian or Alaska Native</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</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="267"/>
                    <measurement group_id="B2" value="266"/>
                    <measurement group_id="B3" value="533"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</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_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</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>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="135"/>
                    <measurement group_id="B2" value="141"/>
                    <measurement group_id="B3" value="276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="138"/>
                    <measurement group_id="B2" value="133"/>
                    <measurement group_id="B3" value="271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint</title>
        <description>Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.</description>
        <time_frame>Randomization until 413 deaths, up to March 2015 (approximately 29 months)</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
          <group group_id="O2">
            <title>Docetaxel</title>
            <description>Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint</title>
          <description>Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.</description>
          <population>All randomized participants</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="292"/>
                <count group_id="O2" value="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.19" lower_limit="9.66" upper_limit="14.98"/>
                    <measurement group_id="O2" value="9.36" lower_limit="8.05" upper_limit="10.68"/>
                  </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>Superiority</non_inferiority_type>
            <p_value>0.0015</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.73</param_value>
            <ci_percent>95.92</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.59</ci_lower_limit>
            <ci_upper_limit>0.89</ci_upper_limit>
            <estimate_desc>HR = Nivolumab over docetaxel</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR)</title>
        <description>ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method.</description>
        <time_frame>From randomization to date of objectively documented progression (up to approximately 110 months)</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
          <group group_id="O2">
            <title>Docetaxel</title>
            <description>Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR)</title>
          <description>ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method.</description>
          <population>All randomized participants</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="292"/>
                <count group_id="O2" value="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.5" lower_limit="15.1" upper_limit="24.5"/>
                    <measurement group_id="O2" value="12.8" lower_limit="9.1" upper_limit="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time To Objective Response (TTOR)</title>
        <description>Time to Objective Response for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.</description>
        <time_frame>From randomization to the date of first confirmed response (up to approximately 110 months)</time_frame>
        <population>All randomized participants who demonstrate partial response (PR) or complete response (CR)</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
          <group group_id="O2">
            <title>Docetaxel</title>
            <description>Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
        </group_list>
        <measure>
          <title>Time To Objective Response (TTOR)</title>
          <description>Time to Objective Response for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.</description>
          <population>All randomized participants who demonstrate partial response (PR) or complete response (CR)</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.10" lower_limit="1.2" upper_limit="34.6"/>
                    <measurement group_id="O2" value="2.73" lower_limit="1.4" upper_limit="31.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Objective Response (DOOR)</title>
        <description>DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment. Median computed using Kaplan-Meier method.</description>
        <time_frame>From randomization to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)</time_frame>
        <population>All randomized participants who demonstrate partial response (PR) or complete response (CR)</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
          <group group_id="O2">
            <title>Docetaxel</title>
            <description>Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Objective Response (DOOR)</title>
          <description>DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment. Median computed using Kaplan-Meier method.</description>
          <population>All randomized participants who demonstrate partial response (PR) or complete response (CR)</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.15" lower_limit="10.78" upper_limit="30.75"/>
                    <measurement group_id="O2" value="5.55" lower_limit="4.40" upper_limit="7.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival (PFS)</title>
        <description>PFS was defined as the time from randomization to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Progression will be assessed every 6 weeks (from the first on-study radiographic assessment) until disease progression is noted. Progressive disease was defined as least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Median computed using the Kaplan-Meier method.</description>
        <time_frame>From randomization to first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
          <group group_id="O2">
            <title>Docetaxel</title>
            <description>Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS)</title>
          <description>PFS was defined as the time from randomization to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Progression will be assessed every 6 weeks (from the first on-study radiographic assessment) until disease progression is noted. Progressive disease was defined as least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Median computed using the Kaplan-Meier method.</description>
          <population>All randomized participants</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="292"/>
                <count group_id="O2" value="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.33" lower_limit="2.17" upper_limit="3.32"/>
                    <measurement group_id="O2" value="4.44" lower_limit="3.45" upper_limit="4.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12</title>
        <description>Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.</description>
        <time_frame>Randomization to Week 12</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
          <group group_id="O2">
            <title>Docetaxel</title>
            <description>Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12</title>
          <description>Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.</description>
          <population>All randomized participants</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="292"/>
                <count group_id="O2" value="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8" lower_limit="13.6" upper_limit="22.7"/>
                    <measurement group_id="O2" value="19.7" lower_limit="15.2" upper_limit="24.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS) by PD-L1 Expression at Baseline</title>
        <description>Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. Median computed using the Kaplan-Meier method.</description>
        <time_frame>From randomization to the date of death or last known date alive (up to approximately 110 months)</time_frame>
        <population>All randomized participants who had a tumor biopsy assessed for PD-L1 expression</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
          <group group_id="O2">
            <title>Docetaxel</title>
            <description>Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) by PD-L1 Expression at Baseline</title>
          <description>Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. Median computed using the Kaplan-Meier method.</description>
          <population>All randomized participants who had a tumor biopsy assessed for PD-L1 expression</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="231"/>
                <count group_id="O2" value="224"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with baseline PD-L1 expression ≥ 5%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.91" lower_limit="15.08" upper_limit="26.12"/>
                    <measurement group_id="O2" value="8.11" lower_limit="6.47" upper_limit="10.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with baseline PD-L1 expression &lt; 5%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                    <count group_id="O2" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.86" lower_limit="6.93" upper_limit="12.81"/>
                    <measurement group_id="O2" value="10.28" lower_limit="8.54" upper_limit="11.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR) by PD-L1 Expression at Baseline</title>
        <description>ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method. ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay.</description>
        <time_frame>From randomization to date of objectively documented progression (up to approximately 110 months)</time_frame>
        <population>All randomized participants who had a tumor biopsy assessed for PD-L1 expression</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
          <group group_id="O2">
            <title>Docetaxel</title>
            <description>Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) by PD-L1 Expression at Baseline</title>
          <description>ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method. ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay.</description>
          <population>All randomized participants who had a tumor biopsy assessed for PD-L1 expression</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="231"/>
                <count group_id="O2" value="224"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with baseline PD-L1 expression ≥ 5%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.2" lower_limit="26.5" upper_limit="46.7"/>
                    <measurement group_id="O2" value="12.8" lower_limit="6.6" upper_limit="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with baseline PD-L1 expression &lt; 5%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                    <count group_id="O2" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" lower_limit="6.3" upper_limit="17.4"/>
                    <measurement group_id="O2" value="14.5" lower_limit="9.1" upper_limit="21.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Overall Survival (OS) - Extended Collection</title>
        <description>Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median computed using Kaplan-Meier method. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until December 17, 2021).</description>
        <time_frame>From randomization to the date of death or last known date alive (up to approximately 110 months)</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
          <group group_id="O2">
            <title>Docetaxel</title>
            <description>Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) - Extended Collection</title>
          <description>Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median computed using Kaplan-Meier method. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until December 17, 2021).</description>
          <population>All randomized participants</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="292"/>
                <count group_id="O2" value="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.21" lower_limit="9.66" upper_limit="15.08"/>
                    <measurement group_id="O2" value="9.49" lower_limit="8.11" upper_limit="10.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 110 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 108 months).</time_frame>
      <desc>All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants.&#xD;
ARM 1: AEs that occurred on 3 mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3 mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab.</desc>
      <group_list>
        <group group_id="E1">
          <title>Nivolumab 3 mg/kg</title>
          <description>Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
        </group>
        <group group_id="E2">
          <title>Nivolumab 480 mg</title>
          <description>Nivolumab 480 mg solution administered intravenously every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
        </group>
        <group group_id="E3">
          <title>Docetaxel</title>
          <description>Docetaxel 75mg/m^2 solution administered intravenously every 3 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
        </group>
        <group group_id="E4">
          <title>Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg</title>
          <description>Eligible participants from the Docetaxel arm who transitioned to nivolumab 3 mg/kg every 2 weeks via extension phase. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
        </group>
        <group group_id="E5">
          <title>Extension Phase of Docetaxel Arm: Nivolumab 480 mg</title>
          <description>Eligible participants from the Docetaxel arm who transitioned to nivolumab 480 mg every 4 weeks via extension phase. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>24.1</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="258" subjects_at_risk="292"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="266" subjects_at_risk="290"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="172" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="161" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haematotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Thrombotic thrombocytopenic purpura</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cardiac tamponade</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cardiovascular disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal tear</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Erosive oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Complication associated with device</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Febrile infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fungal oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastroenteritis norovirus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Infected skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lung abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nail infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonia mycoplasmal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonia necrotising</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Post procedural pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Spontaneous bacterial peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vascular device infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>General physical condition abnormal</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Joint range of motion decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Osteonecrosis of jaw</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Osteoporotic fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Polymyalgia rheumatica</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma recurrent</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lung cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lymphangiosis carcinomatosa</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="58" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="40" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Malignant pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Metastases to meninges</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Metastases to spine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Non-small cell lung cancer</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Non-small cell lung cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oncologic complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ovarian neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pericardial effusion malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Central nervous system necrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hemiplegia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>IVth nerve paresis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nervous system disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Partial seizures</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Disorientation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspnoea at rest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hydrothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lung infiltration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Jugular vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Peripheral artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Peripheral artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Venous thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>24.1</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="267" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="258" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="68" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="29" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="82" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Excessive cerumen production</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tympanic membrane perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="50" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="74" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="72" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="85" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="30" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="60" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="63" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="96" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="104" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="46" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="44" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nodule</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Campylobacter infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood magnesium decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="91" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="64" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="72" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="41" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="35" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="30" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="35" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Motor dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="83" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="67" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="68" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="64" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sputum discoloured</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="70" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Toxic skin eruption</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="287"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="268"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
              </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>Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Bristol-Myers Squibb Study Director</name_or_title>
      <organization>Bristol-Myers Squibb</organization>
      <phone>Please Email</phone>
      <email>Clinical.Trials@bms.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/NCT01673867
org study id: CA209-057
secondary id: 2012-002472-14
nct id: NCT01673867
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as
      compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC)
      after failure of prior platinum-based chemotherapy
CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint
time frame: Randomization until 413 deaths, up to March 2015 (approximately 29 months)
description: Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.
measure: Objective Response Rate (ORR)
time frame: From randomization to date of objectively documented progression (up to approximately 110 months)
description: ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method.
measure: Time To Objective Response (TTOR)
time frame: From randomization to the date of first confirmed response (up to approximately 110 months)
description: Time to Objective Response for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.
measure: Duration of Objective Response (DOOR)
time frame: From randomization to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)
description: DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment. Median computed using Kaplan-Meier method.
measure: Progression-Free Survival (PFS)
time frame: From randomization to first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months)
description: PFS was defined as the time from randomization to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Progression will be assessed every 6 weeks (from the first on-study radiographic assessment) until disease progression is noted. Progressive disease was defined as least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Median computed using the Kaplan-Meier method.
measure: Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12
time frame: Randomization to Week 12
description: Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.
measure: Overall Survival (OS) by PD-L1 Expression at Baseline
time frame: From randomization to the date of death or last known date alive (up to approximately 110 months)
description: Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. Median computed using the Kaplan-Meier method.
measure: Objective Response Rate (ORR) by PD-L1 Expression at Baseline
time frame: From randomization to date of objectively documented progression (up to approximately 110 months)
description: ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CR+PR, confidence interval based on the Clopper and Pearson method. ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay.
arm group label: Arm A: Nivolumab
arm group type: Experimental
description: Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
arm group label: Arm B: Docetaxel
arm group type: Active Comparator
description: Docetaxel 75 mg/m^2 concentrate for solution for intravenous infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
intervention type: Biological
intervention name: Nivolumab
arm group label: Arm A: Nivolumab
other name: BMS-936558 (Anti-PD1)
intervention type: Drug
intervention name: Docetaxel
arm group label: Arm B: Docetaxel
other name: Taxotere®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Argentina
country: Australia
country: Austria
country: Brazil
country: Canada
country: Chile
country: Czechia
country: France
country: Germany
country: Hong Kong
country: Hungary
country: Italy
country: Mexico
country: Norway
country: Peru
country: Poland
country: Romania
country: Russian Federation
country: Singapore
country: Spain
country: Switzerland
country: United States
country: Czech Republic
country: South Africa
country: Turkey
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: Investigator Inquiry Form
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Docetaxel
mesh term: Nivolumab
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 