<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/NCT02983045</url>
  </required_header>
  <id_info>
    <org_study_id>16-214-02</org_study_id>
    <nct_id>NCT02983045</nct_id>
  </id_info>
  <brief_title>A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors</brief_title>
  <acronym>PIVOT-02</acronym>
  <official_title>A Phase 1/2, Open-label, Multicenter Study of the Combination of NKTR-214 and Nivolumab or the Combination of NKTR-214, Nivolumab, and Other Anti-Cancer Therapies in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nektar Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Nektar Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this four-part study, NKTR-214 was administered in combination with nivolumab and&#xD;
      with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 +&#xD;
      nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the&#xD;
      doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet&#xD;
      therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214&#xD;
      + nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet&#xD;
      combination at dosing schedules from Part 3.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part 1 enrolled patients with advanced or metastatic melanoma, renal cell carcinoma (RCC),&#xD;
      non-small cell lung cancer (NSCLC), urothelial carcinoma, or triple negative breast cancer&#xD;
      (TNBC) to determine the recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD) of&#xD;
      NKTR 214 + nivolumab doublet therapy.&#xD;
&#xD;
      Part 2 enrolled patients with advanced or metastatic solid tumor malignancies (including 9&#xD;
      tumor types consisting of the same 5 tumor types as in Part 1, plus hormone receptor positive&#xD;
      human epidermal growth factor receptor 2 [HER 2] negative breast cancer [HR+ HER2- BC],&#xD;
      gastric cancer, colorectal carcinoma, and small cell lung cancer [SCLC]) to assess the&#xD;
      efficacy of the RP2D.&#xD;
&#xD;
      Part 3 enrolled patients with advanced or metastatic melanoma, RCC, NSCLC, or urothelial&#xD;
      carcinoma (UCC) in a first-line setting (1L) to assess the safety and tolerability of NKTR&#xD;
      214 + nivolumab + ipilimumab triplet therapy Three dosing schedules were evaluated to&#xD;
      establish RP2D dosing schedules for Part 4 of the study.&#xD;
&#xD;
      Part 4 planned to enroll patients with advanced or metastatic melanoma, RCC, NSCLC, or UCC to&#xD;
      further assess the efficacy of the RP2D triplet combination at the 3 dosing schedules from&#xD;
      Part 3. Patients were enrolled simultaneously to each tumor cohort.&#xD;
&#xD;
      All patients enrolled in the study were closely monitored for safety, tolerability and&#xD;
      response per RECIST criteria. The primary efficacy endpoint was objective response rate (ORR)&#xD;
      using RECIST 1.1 at the RP2D doublet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2016</start_date>
  <completion_date type="Actual">April 28, 2022</completion_date>
  <primary_completion_date type="Actual">April 28, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part 1 Dose Escalation: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window</measure>
    <time_frame>Includes DLTs that occurred within the DLT window of at least 21 days after the first dose of study treatment (28 days for every 2 weeks dosing; 21 days for every 3 weeks dosing). Patients were counted only once under each preferred term.</time_frame>
    <description>Part 1of the study was a dose-escalation phase that evaluated the safety and tolerability and defined the maximum tolerated dose or recommended Phase 2 dose of the NKTR-214/nivolumab doublet across 5 dosage/schedule levels. The results presented are for the DLT Population.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3 Schedule Finding: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window</measure>
    <time_frame>Dose-limiting toxicities (DLTs) were assessed during a 3-week (21-day) DLT evaluation period beginning with the first dose of ipilimumab.</time_frame>
    <description>Part 3 of the study was a schedule finding phase to establish the recommended phase 2 dosing schedules for Part 4 and assess the safety and tolerability for the NKTR-214/nivolumab/ipilimumab triplet combination. The results presented are for the DLT Population.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2 and Part 4: Objective Response Rate (ORR) Per RECIST 1.1 at Recommended Phase 2 Dose (RP2D)</measure>
    <time_frame>Tumor assessment at Screening then every 8 weeks (± 7 days) from Cycle 1 Day 1 and end of treatment (unless scan done within 4 weeks) up to approximately 27 months.</time_frame>
    <description>Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) at Recommended Phase 2 Dose (RP2D).&#xD;
ORR is defined as the percentage of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to &lt;10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">557</enrollment>
  <condition>Melanoma</condition>
  <condition>Renal Cell Carcinoma</condition>
  <condition>Non Small Cell Lung Cancer</condition>
  <condition>Urothelial Carcinoma</condition>
  <condition>Triple Negative Breast Cancer</condition>
  <condition>HR+/HER2- Breast Cancer</condition>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Dose Escalation: Combination of NKTR-214 + nivolumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NKTR 214 + nivolumab at 5 dosage levels to determine the RP2D Part 1 of RP2D in patients with advanced or metastatic melanoma, RCC, NSCLC, urothelial carcinoma, or TNBC.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Combination of NKTR-214 + nivolumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NKTR-214+nivolumab in patients with advanced or metastatic solid tumor malignancies to assess the efficacy of the RP2D.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: Combination of NKTR-214 + nivolumab + ipilimumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To assess the safety and tolerability of NKTR 214 + nivolumab + ipilimumab triplet therapy and establish RP2D dosing schedules for Part 4 in patients with advanced or metastatic melanoma, RCC, NSCLC, or UCC in a first-line setting (1L).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: Dose Expansion of Part 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To further assess the RP2D triplet combination dosing schedules from Part 3 in 1L NSCLC and 1L RCC patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dose Escalation Doublet: Combination of NKTR-214 + nivolumab</intervention_name>
    <description>NKTR 214 + nivolumab at 5 dosage levels.</description>
    <arm_group_label>Dose Escalation: Combination of NKTR-214 + nivolumab</arm_group_label>
    <other_name>Bempegaldesleukin + Opdivo®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dose Expansion Doublet: Combination of NKTR-214 + nivolumab</intervention_name>
    <description>Select patient cohorts with select tumor types will be dosed with NKTR-214 + nivolumab at the RP2D + other anti-cancer therapies per institution standard.</description>
    <arm_group_label>Dose Expansion: Combination of NKTR-214 + nivolumab</arm_group_label>
    <other_name>Bempegaldesleukin+ Opdivo®</other_name>
    <other_name>Carboplatin (Paraplatin®)</other_name>
    <other_name>Cisplatin (Platinol®)</other_name>
    <other_name>Pemetrexed (Alimta®)</other_name>
    <other_name>Paclitaxel (Taxol®)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab</intervention_name>
    <description>1L patients with RCC, NSCLC, UCC, and melanoma received NKTR-214 0.006 mg/kg q3w in combination with nivolumab and ipilimumab according to 3 dosing schedules.</description>
    <arm_group_label>Experimental: Combination of NKTR-214 + nivolumab + ipilimumab</arm_group_label>
    <other_name>Bempegaldesleukin+ Opdivo®+ Yervoy®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dose Expansion Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab</intervention_name>
    <description>Combination of NKTR-214 + nivolumab + ipilimumab was administered at RP2D dose/schedules in select tumor types</description>
    <arm_group_label>Experimental: Dose Expansion of Part 3</arm_group_label>
    <other_name>Bempegaldesleukin+ Opdivo®+ Yervoy®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA - For Parts 1-4:&#xD;
&#xD;
          -  Histologically confirmed diagnosis of a locally advanced (not amenable to curative&#xD;
             therapy such as surgical resection) or metastatic solid tumors&#xD;
&#xD;
          -  Life expectancy &gt; 12 weeks&#xD;
&#xD;
          -  Patients must not have received prior interleukin-2 (IL-2) therapy&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1&#xD;
&#xD;
          -  Measurable disease per RECIST 1.1&#xD;
&#xD;
          -  Patients with stable brain metastases under certain criteria&#xD;
&#xD;
          -  Fresh and archival tumor tissue available Tumor specific inclusion criteria may apply.&#xD;
&#xD;
        EXCLUSION CRITERIA - For Parts 1-4:&#xD;
&#xD;
          -  Use of an investigational agent or an investigational device within 28 days before&#xD;
             administration of first dose of NKTR--214&#xD;
&#xD;
          -  Females who are pregnant or breastfeeding&#xD;
&#xD;
          -  Participants who have an active autoimmune disease requiring systemic treatment within&#xD;
             the past 3 months or have a documented history of clinically severe autoimmune disease&#xD;
             that requires systemic steroids or immunosuppressive agents&#xD;
&#xD;
          -  History of organ transplant that requires use of immune suppressive agents&#xD;
&#xD;
          -  Active malignancy not related to the current diagnosed malignancy&#xD;
&#xD;
          -  Evidence of clinically significant interstitial lung disease or active, noninfectious&#xD;
             pneumonitis&#xD;
&#xD;
          -  Participants who have had &lt; 28 days since the last chemotherapy, biological therapy,&#xD;
             or &lt; 14 days from approved tyrosine kinase inhibitor (TKI) therapy, or systemic or&#xD;
             inhaled steroid therapy at doses greater than 10mg of prednisone Tumor specific&#xD;
             exclusion criteria may apply.&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria may 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>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Nektar Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSD, Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Cancer Institute</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado, Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06473</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Health Inc.</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center, Chicago</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Health Melvin &amp; Bren Simon Cancer Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University Langone Medical Center - NYU Cancer Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Portland Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax Hospital</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists, PC</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antwerp University Hospital</name>
      <address>
        <city>Edegem</city>
        <zip>02650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vzw Az Groeninge</name>
      <address>
        <city>Kortrijk</city>
        <zip>08500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>03000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Liège</name>
      <address>
        <city>Liège</city>
        <zip>04000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GZA Ziekenhuizen Campus Sint-Augustinus</name>
      <address>
        <city>Wilrijk</city>
        <zip>02610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BC Cancer Agency Vancouver Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>H3T1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G2M10</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>L'Institut Paoli - Calmettes</name>
      <address>
        <city>Marseille</city>
        <state>Brouches-duRhone</state>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancerologie de l'Ouest</name>
      <address>
        <city>Saint-Herblain</city>
        <state>Loire-Atlantique</state>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille - Hopital Nord</name>
      <address>
        <city>Marseille Cedex 20</city>
        <zip>13915</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Nazionale dei Tumori</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori IRCCS &quot;Fondazione G. Pascale&quot;</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Camillo-Forlanini</name>
      <address>
        <city>Roma</city>
        <zip>00152</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Senese</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Cancer Research and Treatment (IRCC)</name>
      <address>
        <city>Turin</city>
        <zip>10060</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza</name>
      <address>
        <city>Brzozów</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpitale Pomorskie Sp. z o.o.</name>
      <address>
        <city>Gdynia</city>
        <zip>81519</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy</name>
      <address>
        <city>Otwock</city>
        <zip>05400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wielkopolskie Centrum Pulmonologii i Torakochirurgii</name>
      <address>
        <city>Poznań</city>
        <zip>60569</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Med-Polonia Sp. z o.o.</name>
      <address>
        <city>Poznań</city>
        <zip>60693</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instytut Medyczny Santa Familia Sp. z o. o. w Łodzi</name>
      <address>
        <city>Łódź</city>
        <zip>93509</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quirón Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>8023</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>8036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Integral Oncológico Clara Campal (CIOCC)</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Universidad de Navarra</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden NHS Trust</name>
      <address>
        <city>London</city>
        <zip>SM25PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Cancer Centre</name>
      <address>
        <city>Northwood</city>
        <zip>HA62RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust</name>
      <address>
        <city>Withington</city>
        <zip>M204BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Ukraine</country>
  </removed_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <results_first_submitted>November 29, 2022</results_first_submitted>
  <results_first_submitted_qc>March 9, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 13, 2023</results_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NKTR-214</keyword>
  <keyword>Bempegaldesleukin</keyword>
  <keyword>Nivolumab</keyword>
  <keyword>Paclitaxel</keyword>
  <keyword>Carboplatin</keyword>
  <keyword>Cisplatin</keyword>
  <keyword>Pemetrexed</keyword>
  <keyword>Melanoma</keyword>
  <keyword>Renal Cell Carcinoma</keyword>
  <keyword>Non Small Cell Lung Cancer</keyword>
  <keyword>Urothelial Carcinoma</keyword>
  <keyword>Triple Negative Breast Cancer</keyword>
  <keyword>HR+/HER2- Breast Cancer</keyword>
  <keyword>Gastric Cancer</keyword>
  <keyword>Colorectal Cancer</keyword>
  <keyword>Metastatic</keyword>
  <keyword>Advanced</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>Anti-PD-1</keyword>
  <keyword>anti-CTLA-4</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Transitional Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
    <mesh_term>Ipilimumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT02983045/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 2, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT02983045/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Part 1 Dose Escalation Cohort 1: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (240 mg) q2w</title>
          <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 240 mg nivolumab q2w.</description>
        </group>
        <group group_id="P2">
          <title>Part 1 Dose Escalation Cohort 2: NKTR-214 (0.006 mg/kg) q2w + Nivolumab (240 mg) q2w</title>
          <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.006 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.</description>
        </group>
        <group group_id="P3">
          <title>Part 1 Dose Escalation Cohort 3: NKTR-214 (0.003 mg/kg) q2w + Nivolumab (240 mg) q2w</title>
          <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.003 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.</description>
        </group>
        <group group_id="P4">
          <title>Part 1 Dose Escalation Cohort 4: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w</title>
          <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.</description>
        </group>
        <group group_id="P5">
          <title>Part 1 Dose Escalation Cohort 5: NKTR-214 (0.009 mg/kg) q3w + Nivolumab (360 mg) q3w</title>
          <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.009 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.</description>
        </group>
        <group group_id="P6">
          <title>Part 2 Dose Expansion: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w</title>
          <description>In this Part 2 of the study, the patients will receive a combination of NKTR-214 + nivolumab at the RP2D (NKTR 214 0.006 mg/kg q3w + nivolumab 360 mg q3w) with or without chemotherapy.</description>
        </group>
        <group group_id="P7">
          <title>Part 3 Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab</title>
          <description>In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4.&#xD;
In Schedule 1, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 360 mg flat dose q3w + ipilimumab at 1 mg/kg q6w.</description>
        </group>
        <group group_id="P8">
          <title>Part 3 Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab</title>
          <description>In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4.&#xD;
In Schedule 2, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 1 mg/kg q3w + ipilimumab at 3 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.</description>
        </group>
        <group group_id="P9">
          <title>Part 3 Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab</title>
          <description>In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4.&#xD;
In Schedule 3, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 3 mg/kg q3w + ipilimumab at 1 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.</description>
        </group>
        <group group_id="P10">
          <title>Part 4 Dose Expansion of NKTR-214 + Nivolumab + Ipilimumab</title>
          <description>Experimental Combination of NKTR-214 + nivolumab + ipilimumab&#xD;
Combination of NKTR-214 + nivolumab: Combination of NKTR-214 + nivolumab +ipilimumab administered at the RP2D dose/schedule.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="25"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="476"/>
                <participants group_id="P7" count="10"/>
                <participants group_id="P8" count="8"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="20"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="394"/>
                <participants group_id="P7" count="10"/>
                <participants group_id="P8" count="8"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="82"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="72"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="2"/>
              </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="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="10"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Part 1 Dose Escalation Cohort 1: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (240 mg) q2w</title>
          <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 240 mg nivolumab q2w.</description>
        </group>
        <group group_id="B2">
          <title>Part 1 Dose Escalation Cohort 2: NKTR-214 (0.006 mg/kg) q2w + Nivolumab (240 mg) q2w</title>
          <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.006 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.</description>
        </group>
        <group group_id="B3">
          <title>Part 1 Dose Escalation Cohort 3: NKTR-214 (0.003 mg/kg) q2w + Nivolumab (240 mg) q2w</title>
          <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.003 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.</description>
        </group>
        <group group_id="B4">
          <title>Part 1 Dose Escalation Cohort 4: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w</title>
          <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.</description>
        </group>
        <group group_id="B5">
          <title>Part 1 Dose Escalation Cohort 5: NKTR-214 (0.009 mg/kg) q3w + Nivolumab (360 mg) q3w</title>
          <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.009 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.</description>
        </group>
        <group group_id="B6">
          <title>Part 2 Dose Expansion: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w</title>
          <description>In this Part 2 of the study, the patients will receive a combination of NKTR-214 + nivolumab at the RP2D (NKTR 214 0.006 mg/kg q3w + nivolumab 360 mg q3w) with or without chemotherapy.</description>
        </group>
        <group group_id="B7">
          <title>Part 3 Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab</title>
          <description>In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4.&#xD;
In Schedule 1, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 360 mg flat dose q3w + ipilimumab at 1 mg/kg q6w.</description>
        </group>
        <group group_id="B8">
          <title>Part 3 Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab</title>
          <description>In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4.&#xD;
In Schedule 2, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 1 mg/kg q3w + ipilimumab at 3 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.</description>
        </group>
        <group group_id="B9">
          <title>Part 3 Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab</title>
          <description>In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4.&#xD;
In Schedule 3, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 3 mg/kg q3w + ipilimumab at 1 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.</description>
        </group>
        <group group_id="B10">
          <title>Part 4 Dose Expansion of NKTR-214 + Nivolumab + Ipilimumab</title>
          <description>Experimental Combination of NKTR-214 + nivolumab ipilimumab that may enroll between 12-26 patients per tumor type&#xD;
Combination of NKTR-214 + nivolumab: Combination of NKTR-214 + nivolumab +ipilimumab administered at the RP2D dose/schedule.</description>
        </group>
        <group group_id="B11">
          <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="4"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="3"/>
            <count group_id="B4" value="25"/>
            <count group_id="B5" value="3"/>
            <count group_id="B6" value="476"/>
            <count group_id="B7" value="10"/>
            <count group_id="B8" value="8"/>
            <count group_id="B9" value="6"/>
            <count group_id="B10" value="19"/>
            <count group_id="B11" value="557"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.8" spread="10.90"/>
                    <measurement group_id="B2" value="61.7" spread="7.37"/>
                    <measurement group_id="B3" value="57.0" spread="7.81"/>
                    <measurement group_id="B4" value="59.2" spread="10.12"/>
                    <measurement group_id="B5" value="55.7" spread="6.81"/>
                    <measurement group_id="B6" value="62.1" spread="11.48"/>
                    <measurement group_id="B7" value="62.4" spread="9.45"/>
                    <measurement group_id="B8" value="64.3" spread="5.85"/>
                    <measurement group_id="B9" value="61.2" spread="9.3"/>
                    <measurement group_id="B10" value="59.1" spread="12.63"/>
                    <measurement group_id="B11" value="61.7" spread="11.32"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="207"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="5"/>
                    <measurement group_id="B11" value="221"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="269"/>
                    <measurement group_id="B7" value="9"/>
                    <measurement group_id="B8" value="8"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="14"/>
                    <measurement group_id="B11" value="336"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="35"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="413"/>
                    <measurement group_id="B7" value="9"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="4"/>
                    <measurement group_id="B10" value="15"/>
                    <measurement group_id="B11" value="480"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="28"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="13"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="16"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="413"/>
                    <measurement group_id="B7" value="8"/>
                    <measurement group_id="B8" value="7"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="17"/>
                    <measurement group_id="B11" value="486"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="31"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="27"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="29"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="295"/>
                    <measurement group_id="B7" value="10"/>
                    <measurement group_id="B8" value="8"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="19"/>
                    <measurement group_id="B11" value="376"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="23"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="35"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="14"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="47"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ECOG Performance Status</title>
          <description>Eastern Cooperative Oncology Group (ECOG) performance status:&#xD;
ECOG Performance Status of 0 = Able to carry out all normal activities without restriction&#xD;
ECOG Performance Status of 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="221"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="12"/>
                    <measurement group_id="B11" value="276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="254"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="7"/>
                    <measurement group_id="B11" value="280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Data Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Part 1 Dose Escalation: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window</title>
        <description>Part 1of the study was a dose-escalation phase that evaluated the safety and tolerability and defined the maximum tolerated dose or recommended Phase 2 dose of the NKTR-214/nivolumab doublet across 5 dosage/schedule levels. The results presented are for the DLT Population.</description>
        <time_frame>Includes DLTs that occurred within the DLT window of at least 21 days after the first dose of study treatment (28 days for every 2 weeks dosing; 21 days for every 3 weeks dosing). Patients were counted only once under each preferred term.</time_frame>
        <population>The DLT population included all Part 1 patients who took study treatment and followed up at least through the DLT evaluation period (q2w dosing: received ≥ 2 cycles of study treatment and stayed in study for at least 28 days; q3w dosing: received at least 1 cycle of study treatment and stayed in study for at least 21 days) or discontinued from study treatment due to DLT.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Escalation Cohort 1: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (240 mg) q2w</title>
            <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 240 mg nivolumab q2w.</description>
          </group>
          <group group_id="O2">
            <title>Dose Escalation Cohort 2: NKTR-214 (0.006 mg/kg) q2w + Nivolumab (240 mg) q2w</title>
            <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.006 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.</description>
          </group>
          <group group_id="O3">
            <title>Dose Escalation Cohort 3: NKTR-214 (0.003 mg/kg) q2w + Nivolumab (240 mg) q2w</title>
            <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.003 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.</description>
          </group>
          <group group_id="O4">
            <title>Dose Escalation Cohort 4: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w</title>
            <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.</description>
          </group>
          <group group_id="O5">
            <title>Dose Escalation Cohort 5: NKTR-214 (0.009 mg/kg) q3w + Nivolumab (360 mg) q3w</title>
            <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.009 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1 Dose Escalation: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window</title>
          <description>Part 1of the study was a dose-escalation phase that evaluated the safety and tolerability and defined the maximum tolerated dose or recommended Phase 2 dose of the NKTR-214/nivolumab doublet across 5 dosage/schedule levels. The results presented are for the DLT Population.</description>
          <population>The DLT population included all Part 1 patients who took study treatment and followed up at least through the DLT evaluation period (q2w dosing: received ≥ 2 cycles of study treatment and stayed in study for at least 28 days; q3w dosing: received at least 1 cycle of study treatment and stayed in study for at least 21 days) or discontinued from study treatment due to DLT.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="24"/>
                <count group_id="O5" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At least 1 DLT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolism and Nutrition Disorders: Acidosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolism and Nutrition Disorders: Hyperglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vascular Disorders: Hypotension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 3 Schedule Finding: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window</title>
        <description>Part 3 of the study was a schedule finding phase to establish the recommended phase 2 dosing schedules for Part 4 and assess the safety and tolerability for the NKTR-214/nivolumab/ipilimumab triplet combination. The results presented are for the DLT Population.</description>
        <time_frame>Dose-limiting toxicities (DLTs) were assessed during a 3-week (21-day) DLT evaluation period beginning with the first dose of ipilimumab.</time_frame>
        <population>The DLT population included all Part 3 patients who received at least 1 cycle of study treatment and stayed in study for at least 21 days after first dose of ipilimumab or discontinued from study treatment due to DLT.</population>
        <group_list>
          <group group_id="O1">
            <title>Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab</title>
            <description>In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4.&#xD;
In Schedule 1, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 360 mg flat dose q3w + ipilimumab at 1 mg/kg q6w.</description>
          </group>
          <group group_id="O2">
            <title>Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab</title>
            <description>In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4.&#xD;
In Schedule 2, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 1 mg/kg q3w + ipilimumab at 3 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.</description>
          </group>
          <group group_id="O3">
            <title>Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab</title>
            <description>In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4.&#xD;
In Schedule 3, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 3 mg/kg q3w + ipilimumab at 1 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 3 Schedule Finding: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window</title>
          <description>Part 3 of the study was a schedule finding phase to establish the recommended phase 2 dosing schedules for Part 4 and assess the safety and tolerability for the NKTR-214/nivolumab/ipilimumab triplet combination. The results presented are for the DLT Population.</description>
          <population>The DLT population included all Part 3 patients who received at least 1 cycle of study treatment and stayed in study for at least 21 days after first dose of ipilimumab or discontinued from study treatment due to DLT.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patients with at least one event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endocrine disorders: Adrenal insufficiency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endocrine disorders: Hyperthyroidism</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolism and nutrition disorders: Hyponatraemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2 and Part 4: Objective Response Rate (ORR) Per RECIST 1.1 at Recommended Phase 2 Dose (RP2D)</title>
        <description>Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) at Recommended Phase 2 Dose (RP2D).&#xD;
ORR is defined as the percentage of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to &lt;10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.</description>
        <time_frame>Tumor assessment at Screening then every 8 weeks (± 7 days) from Cycle 1 Day 1 and end of treatment (unless scan done within 4 weeks) up to approximately 27 months.</time_frame>
        <population>The response evaluable population included patients who had measurable disease (per RECIST 1.1) at baseline and also had at least 1 postbaseline assessment of tumor response prior to receiving new systemic anticancer therapy, surgical procedures or radiotherapy on target lesions.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Dose Expansion: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w</title>
            <description>In this Part 2 of the study, the patients received a combination of NKTR-214 + nivolumab at the RP2D (NKTR 214 0.006 mg/kg q3w + nivolumab 360 mg q3w) with or without chemotherapy.</description>
          </group>
          <group group_id="O2">
            <title>Part 4 Dose Expansion of NKTR-214 + Nivolumab + Ipilimumab</title>
            <description>Experimental Combination of NKTR-214 + nivolumab + ipilimumab&#xD;
Combination of NKTR-214 + nivolumab: Combination of NKTR-214 + nivolumab +ipilimumab administered at the RP2D dose/schedule.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2 and Part 4: Objective Response Rate (ORR) Per RECIST 1.1 at Recommended Phase 2 Dose (RP2D)</title>
          <description>Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) at Recommended Phase 2 Dose (RP2D).&#xD;
ORR is defined as the percentage of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to &lt;10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.</description>
          <population>The response evaluable population included patients who had measurable disease (per RECIST 1.1) at baseline and also had at least 1 postbaseline assessment of tumor response prior to receiving new systemic anticancer therapy, surgical procedures or radiotherapy on target lesions.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="429"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 2.5 years.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Part 1 Dose Escalation Cohort 1: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (240 mg) q2w</title>
          <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 240 mg nivolumab q2w.</description>
        </group>
        <group group_id="E2">
          <title>Part 1 Dose Escalation Cohort 2: NKTR-214 (0.006 mg/kg) q2w + Nivolumab (240 mg) q2w</title>
          <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.006 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.</description>
        </group>
        <group group_id="E3">
          <title>Part 1 Dose Escalation Cohort 3: NKTR-214 (0.003 mg/kg) q2w + Nivolumab (240 mg) q2w</title>
          <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.003 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.</description>
        </group>
        <group group_id="E4">
          <title>Part 1 Dose Escalation Cohort 4: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w</title>
          <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.</description>
        </group>
        <group group_id="E5">
          <title>Part 1 Dose Escalation Cohort 5: NKTR-214 (0.009 mg/kg) q3w + Nivolumab (360 mg) q3w</title>
          <description>NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D.&#xD;
Patients will receive NKTR-214 at 0.009 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.</description>
        </group>
        <group group_id="E6">
          <title>Part 2 Dose Expansion: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w</title>
          <description>In this Part 2 of the study, the patients will receive a combination of NKTR-214 + nivolumab at the RP2D (NKTR 214 0.006 mg/kg q3w + nivolumab 360 mg q3w) with or without chemotherapy.</description>
        </group>
        <group group_id="E7">
          <title>Part 3 Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab</title>
          <description>In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4.&#xD;
In Schedule 1, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 360 mg flat dose q3w + ipilimumab at 1 mg/kg q6w.</description>
        </group>
        <group group_id="E8">
          <title>Part 3 Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab</title>
          <description>In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4.&#xD;
In Schedule 2, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 1 mg/kg q3w + ipilimumab at 3 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.</description>
        </group>
        <group group_id="E9">
          <title>Part 3 Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab</title>
          <description>In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4.&#xD;
In Schedule 3, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 3 mg/kg q3w + ipilimumab at 1 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.</description>
        </group>
        <group group_id="E10">
          <title>Part 4 Dose Expansion of NKTR-214 + Nivolumab + Ipilimumab</title>
          <description>Experimental Combination of NKTR-214 + nivolumab + ipilimumab. Combination of NKTR-214 + nivolumab: Combination of NKTR-214 + nivolumab +ipilimumab administered at the RP2D dose/schedule.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Non-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="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="291" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="213" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="8" subjects_at_risk="19"/>
              </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="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypereosinophilic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Microcytic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Arrhythmia supraventricular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Autoimmune hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypophysitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Thyroiditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Oesophageal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Contrast media allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Corona virus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Abscess soft tissue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Bursitis infective staphylococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Systemic infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Multiple fractures</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Tumour haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Intracranial tumour haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Oesophageal squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Myasthenia gravis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Vasogenic cerebral oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </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="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Autoimmune nephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Obstructive uropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Bronchial obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Diaphragmatic spasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Laryngeal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Drug reaction with eosinophilia and systemic symptoms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pemphigoid</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="15" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Superior vena cava syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Vena cava thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Venous thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Non-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="4" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="25" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="468" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="8" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="19" subjects_at_risk="19"/>
              </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="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="51" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Heparin-induced thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="17" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Stress cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </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="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="65" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="25" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Thyroiditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypogonadism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypophysitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Periorbital oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Eyelid oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Vitreous floaters</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Orbital oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Chalazion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="191" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="11" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="126" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="10" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="117" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="98" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="57" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="50" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="35" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="29" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="21" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Swollen tongue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Tongue oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Anal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia oral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Oral disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Oral dysaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Retching</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Abdominal rigidity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Lip oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Salivary gland pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="241" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="9" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="15" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="228" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="10" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="126" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="13" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="115" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="90" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="70" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="27" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="24" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="23" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="20" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="17" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Localised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Axillary pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypothermia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Contrast media allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="35" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="28" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Mucosal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gastroenteritis pseudomonas</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Groin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pneumonia streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Post procedural cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="29" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Sunburn</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gastrointestinal stoma complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="64" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="30" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="18" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Eosinophil count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Troponin I increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Blood creatine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </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="3" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="168" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="9" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="41" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="23" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="19" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="17" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </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="4" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="114" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="80" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="68" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="45" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="30" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="28" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="19" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="17" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Joint stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Joint range of motion decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Plantar fasciitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Soft tissue swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Skin neoplasm bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="73" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="79" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="32" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="28" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="18" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dysaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Akathisia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Balint's syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hemianopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Vasogenic cerebral oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Visual field defect</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="51" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Claustrophobia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Chromaturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Bladder spasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Nephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Nephrotic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Urine odour abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Testicular pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Perineal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </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="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="118" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="94" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="49" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="34" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="24" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="20" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="19" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="19" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="18" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="18" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pharyngeal oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Sputum increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Upper airway obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hyperventilation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pulmonary pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Throat tightness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="181" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="9" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="123" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="73" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="11" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="63" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="45" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="23" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="18" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="17" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="15" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Skin hypopigmentation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Vitiligo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dermatitis exfoliative</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dermatitis bullous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pain of skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Skin mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Eczema asteatotic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Keloid scar</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rash vesicular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Skin induration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="77" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="31" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="20" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="476"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There are restrictions to the PI's rights to discuss or publish trial results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Nektar Therapeutics</organization>
      <phone>855-482-8676</phone>
      <email>StudyInquiry@nektar.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/NCT02983045
org study id: 16-214-02
nct id: NCT02983045
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
In this four-part study, NKTR-214 was administered in combination with nivolumab and
      with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 +
      nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the
      doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet
      therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214
      + nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet
      combination at dosing schedules from Part 3.
Part 1 enrolled patients with advanced or metastatic melanoma, renal cell carcinoma (RCC),
      non-small cell lung cancer (NSCLC), urothelial carcinoma, or triple negative breast cancer
      (TNBC) to determine the recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD) of
      NKTR 214 + nivolumab doublet therapy.

      Part 2 enrolled patients with advanced or metastatic solid tumor malignancies (including 9
      tumor types consisting of the same 5 tumor types as in Part 1, plus hormone receptor positive
      human epidermal growth factor receptor 2 [HER 2] negative breast cancer [HR+ HER2- BC],
      gastric cancer, colorectal carcinoma, and small cell lung cancer [SCLC]) to assess the
      efficacy of the RP2D.

      Part 3 enrolled patients with advanced or metastatic melanoma, RCC, NSCLC, or urothelial
      carcinoma (UCC) in a first-line setting (1L) to assess the safety and tolerability of NKTR
      214 + nivolumab + ipilimumab triplet therapy Three dosing schedules were evaluated to
      establish RP2D dosing schedules for Part 4 of the study.

      Part 4 planned to enroll patients with advanced or metastatic melanoma, RCC, NSCLC, or UCC to
      further assess the efficacy of the RP2D triplet combination at the 3 dosing schedules from
      Part 3. Patients were enrolled simultaneously to each tumor cohort.

      All patients enrolled in the study were closely monitored for safety, tolerability and
      response per RECIST criteria. The primary efficacy endpoint was objective response rate (ORR)
      using RECIST 1.1 at the RP2D doublet.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Part 1 Dose Escalation: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window
time frame: Includes DLTs that occurred within the DLT window of at least 21 days after the first dose of study treatment (28 days for every 2 weeks dosing; 21 days for every 3 weeks dosing). Patients were counted only once under each preferred term.
description: Part 1of the study was a dose-escalation phase that evaluated the safety and tolerability and defined the maximum tolerated dose or recommended Phase 2 dose of the NKTR-214/nivolumab doublet across 5 dosage/schedule levels. The results presented are for the DLT Population.
measure: Part 3 Schedule Finding: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window
time frame: Dose-limiting toxicities (DLTs) were assessed during a 3-week (21-day) DLT evaluation period beginning with the first dose of ipilimumab.
description: Part 3 of the study was a schedule finding phase to establish the recommended phase 2 dosing schedules for Part 4 and assess the safety and tolerability for the NKTR-214/nivolumab/ipilimumab triplet combination. The results presented are for the DLT Population.
measure: Part 2 and Part 4: Objective Response Rate (ORR) Per RECIST 1.1 at Recommended Phase 2 Dose (RP2D)
time frame: Tumor assessment at Screening then every 8 weeks (± 7 days) from Cycle 1 Day 1 and end of treatment (unless scan done within 4 weeks) up to approximately 27 months.
description: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) at Recommended Phase 2 Dose (RP2D).
ORR is defined as the percentage of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.
arm group label: Dose Escalation: Combination of NKTR-214 + nivolumab
arm group type: Experimental
description: NKTR 214 + nivolumab at 5 dosage levels to determine the RP2D Part 1 of RP2D in patients with advanced or metastatic melanoma, RCC, NSCLC, urothelial carcinoma, or TNBC.
arm group label: Dose Expansion: Combination of NKTR-214 + nivolumab
arm group type: Experimental
description: NKTR-214+nivolumab in patients with advanced or metastatic solid tumor malignancies to assess the efficacy of the RP2D.
arm group label: Experimental: Combination of NKTR-214 + nivolumab + ipilimumab
arm group type: Experimental
description: To assess the safety and tolerability of NKTR 214 + nivolumab + ipilimumab triplet therapy and establish RP2D dosing schedules for Part 4 in patients with advanced or metastatic melanoma, RCC, NSCLC, or UCC in a first-line setting (1L).
arm group label: Experimental: Dose Expansion of Part 3
arm group type: Experimental
description: To further assess the RP2D triplet combination dosing schedules from Part 3 in 1L NSCLC and 1L RCC patients.
intervention type: Drug
intervention name: Dose Escalation Doublet: Combination of NKTR-214 + nivolumab
description: NKTR 214 + nivolumab at 5 dosage levels.
arm group label: Dose Escalation: Combination of NKTR-214 + nivolumab
other name: Bempegaldesleukin + Opdivo®
intervention type: Drug
intervention name: Dose Expansion Doublet: Combination of NKTR-214 + nivolumab
description: Select patient cohorts with select tumor types will be dosed with NKTR-214 + nivolumab at the RP2D + other anti-cancer therapies per institution standard.
arm group label: Dose Expansion: Combination of NKTR-214 + nivolumab
other name: Bempegaldesleukin+ Opdivo®
other name: Carboplatin (Paraplatin®)
other name: Cisplatin (Platinol®)
other name: Pemetrexed (Alimta®)
other name: Paclitaxel (Taxol®)
intervention type: Drug
intervention name: Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
description: 1L patients with RCC, NSCLC, UCC, and melanoma received NKTR-214 0.006 mg/kg q3w in combination with nivolumab and ipilimumab according to 3 dosing schedules.
arm group label: Experimental: Combination of NKTR-214 + nivolumab + ipilimumab
other name: Bempegaldesleukin+ Opdivo®+ Yervoy®
intervention type: Drug
intervention name: Dose Expansion Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
description: Combination of NKTR-214 + nivolumab + ipilimumab was administered at RP2D dose/schedules in select tumor types
arm group label: Experimental: Dose Expansion of Part 3
other name: Bempegaldesleukin+ Opdivo®+ Yervoy®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Nektar Therapeutics
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country: Belgium
country: Canada
country: France
country: Italy
country: Poland
country: Spain
country: United Kingdom
country: United States
country: Ukraine
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Breast Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Melanoma
mesh term: Stomach Neoplasms
mesh term: Carcinoma, Renal Cell
mesh term: Triple Negative Breast Neoplasms
mesh term: Carcinoma, Transitional Cell
mesh term: Paclitaxel
mesh term: Cisplatin
mesh term: Carboplatin
mesh term: Nivolumab
mesh term: Pemetrexed
mesh term: Ipilimumab
sharing ipd: No
provided document: 
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reported events: 
certain agreements: 
point of contact: 