<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/NCT02217410</url>
  </required_header>
  <id_info>
    <org_study_id>CCFZ533X2201</org_study_id>
    <nct_id>NCT02217410</nct_id>
  </id_info>
  <brief_title>CCFZ533X2201 - PoC Study in de Novo Renal Transplantation</brief_title>
  <official_title>A 12-month Randomized, Multiple Dose, Open-label, Study Evaluating Safety, Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) and Efficacy of an Anti-CD40 Monoclonal Antibody, CFZ533, in Combination With Mycophenolate Mofetil (MMF) and Corticosteroids (CS), With and Without Tacrolimus (Tac), in de Novo Renal Transplant Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK)&#xD;
      and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar&#xD;
      rate of acute rejection prophylaxis and renal function in a de novo renal transplant&#xD;
      population receiving an allograft from standard criteria donors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2015</start_date>
  <completion_date type="Actual">November 29, 2017</completion_date>
  <primary_completion_date type="Actual">November 29, 2017</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Cmax Pharmacokinetic Parameter- Part I</measure>
    <time_frame>Day 1</time_frame>
    <description>Pharmacokinetics as defined by the systemic concentrations and Cmax of certain immunosuppressant medications used in Part I</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Tmax Pharmacokinetic Parameter - Part I</measure>
    <time_frame>Day 1</time_frame>
    <description>Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean AUClast Pharmacokinetic Parameter - Part I</measure>
    <time_frame>Day 1</time_frame>
    <description>Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy as Defined by the Frequency and Severity (Banff Classification) of Treated Biopsy Proven Acute Rejection (tBPAR) Adjudicated Data - Part II</measure>
    <time_frame>3, 6, 9, and 12 months</time_frame>
    <description>To assess the activity of the investigational arm as compared to the standard of care control arm in de novo renal transplant patients as measured by the frequency and severity of tBPAR as measured on the Banff classification scale.&#xD;
An adjudication was performed on all on cause renal biopsies by an independent expert committee blinded to therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Soluble CD40 and Total Soluble CD154 Concentrations in Plasma - Part 1</measure>
    <time_frame>Baseline to end of study (Day 1, Day 29, Day 337)</time_frame>
    <description>To quantify the change from baseline and recovery of peripheral blood total soluble CD40 and total soluble CD154</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Free CD40 and Total CD40 on B Cells - Part II</measure>
    <time_frame>Baseline to end of study (Day 1/predose)</time_frame>
    <description>The magnitude and duration of peripheral blood CD40 occupancy. MESF: molecules of equivalent soluble fluorochrome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-CFZ533 Antibodies - Part I</measure>
    <time_frame>Baseline to end of study</time_frame>
    <description>To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-CFZ533 Antibodies - Part II</measure>
    <time_frame>Baseline to end of study (screening, baseline, Day 141, Day 225, Day 309, Study Completion)</time_frame>
    <description>To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>eGFR - Part II</measure>
    <time_frame>Day 1, Day 29, Day 337,</time_frame>
    <description>Renal function as assessed by MDRD (Modification of Diet in Renal Disease) formula.&#xD;
eGFR: Estimated glomerular filtration rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CFZ533 Plasma PK Concentrations - Part II</measure>
    <time_frame>throughout study period (day 84 to day 336)</time_frame>
    <description>Quantify the systemic concentrations of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods. A full pharmacokinetic analysis can be performed on the concentration-time data to evaluate the impact of renal transplantation on the various medications used in the treatment regimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total sCD40 Plasma Concentrations - Part II</measure>
    <time_frame>12 months</time_frame>
    <description>To quantify the change from baseline and recovery of peripheral blood total soluble CD40</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Kidney Transplantation</condition>
  <arm_group>
    <arm_group_label>Regimen A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CFZ533 administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CFZ533 administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction]</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CFZ533</intervention_name>
    <arm_group_label>Regimen A</arm_group_label>
    <arm_group_label>Regimen B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tacrolimus (Tac)</intervention_name>
    <arm_group_label>Regimen A</arm_group_label>
    <arm_group_label>Regimen C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycophenolate mofetil (MMF)</intervention_name>
    <arm_group_label>Regimen A</arm_group_label>
    <arm_group_label>Regimen B</arm_group_label>
    <arm_group_label>Regimen C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corticosteroids (CS)</intervention_name>
    <arm_group_label>Regimen A</arm_group_label>
    <arm_group_label>Regimen B</arm_group_label>
    <arm_group_label>Regimen C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>anti-IL2 Induction</intervention_name>
    <arm_group_label>Regimen B</arm_group_label>
    <arm_group_label>Regimen C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent must be obtained before any assessment is performed.&#xD;
&#xD;
          -  Recipients of a kidney transplant from a heart-beating deceased, living unrelated or&#xD;
             non-human leukocyte antigen (HLA) identical living related donor.&#xD;
&#xD;
          -  Recipients of a kidney with a cold ischemia time (CIT) &lt; 30 hours.&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          -  Recipients of an organ from a non-heart beating donor.&#xD;
&#xD;
          -  ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive&#xD;
             transplant.&#xD;
&#xD;
          -  Subjects receiving a second kidney allograft, unless the first allograft was lost due&#xD;
             to surgical complication.&#xD;
&#xD;
          -  Subjects at high immunological risk for rejection&#xD;
&#xD;
          -  Subjects at risk for tuberculosis (TB)&#xD;
&#xD;
          -  Subject with severe systemic infections, current or within the two weeks prior to&#xD;
             randomization/enrollment.&#xD;
&#xD;
          -  Any additional contraindication to the use of tacrolimus or mycophenolate mofetil&#xD;
             according to the national labeling information of these products (see local product&#xD;
             label).&#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>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109 5271</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Livingston</city>
        <state>New Jersey</state>
        <zip>07039</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267-0585</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>04038-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>D-13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Utrecht</city>
        <state>The Netherlands</state>
        <zip>3508 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rotterdam</city>
        <zip>3000 CA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=420</url>
    <description>Plain Language Trial Summary is available on novartisclinicaltrials.com</description>
  </link>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <results_first_submitted>November 28, 2018</results_first_submitted>
  <results_first_submitted_qc>November 28, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 21, 2018</results_first_posted>
  <last_update_submitted>September 24, 2021</last_update_submitted>
  <last_update_submitted_qc>September 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>renal, de novo,</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycophenolic Acid</mesh_term>
    <mesh_term>Tacrolimus</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
  </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>September 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT02217410/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>January 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT02217410/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>In Part 1, patients were enrolled into Arm 1. In Part 2, patients were randomized (2:1) to Arms 2A and 2B.</recruitment_details>
      <pre_assignment_details>Study Part 1 focused on measuring the multiple-dose safety, tolerability, PK, and PD of both IV and SC CFZ533 when administered with the SoC treatment regimen.&#xD;
Study Part 2 investigated efficacy, safety, tolerability, PK and PD of CFZ533 in the absence of Tac.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CFZ533 + TAC + MMF (Part 1)</title>
          <description>CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).</description>
        </group>
        <group group_id="P2">
          <title>CFZ533 + MMF (Part 2)</title>
          <description>CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction</description>
        </group>
        <group group_id="P3">
          <title>Tac + MMF (Part 2)</title>
          <description>Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction]</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="34"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Graft Loss</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" 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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Safety Analysis Set included all patients that received at least one dose of study drug.&#xD;
For Part 2, all patients that received their transplant along with any patient who received study drug but had no transplant were combined.</population>
      <group_list>
        <group group_id="B1">
          <title>CFZ533 + TAC + MMF (Part 1)</title>
          <description>CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).</description>
        </group>
        <group group_id="B2">
          <title>CFZ533 + MMF (Part 2)</title>
          <description>CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction</description>
        </group>
        <group group_id="B3">
          <title>Tac + MMF (Part 2)</title>
          <description>Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction]</description>
        </group>
        <group group_id="B4">
          <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="7"/>
            <count group_id="B2" value="34"/>
            <count group_id="B3" value="18"/>
            <count group_id="B4" value="59"/>
          </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="48.1" spread="9.30"/>
                    <measurement group_id="B2" value="49.0" spread="15.79"/>
                    <measurement group_id="B3" value="53.4" spread="18.01"/>
                    <measurement group_id="B4" value="50.1" spread="15.91"/>
                  </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="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="42"/>
                  </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="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Cmax Pharmacokinetic Parameter- Part I</title>
        <description>Pharmacokinetics as defined by the systemic concentrations and Cmax of certain immunosuppressant medications used in Part I</description>
        <time_frame>Day 1</time_frame>
        <population>The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>CFZ533 + TAC + MMF (Part 1)</title>
            <description>CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Cmax Pharmacokinetic Parameter- Part I</title>
          <description>Pharmacokinetics as defined by the systemic concentrations and Cmax of certain immunosuppressant medications used in Part I</description>
          <population>The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data.</population>
          <units>ug/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.3" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Tmax Pharmacokinetic Parameter - Part I</title>
        <description>Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods.</description>
        <time_frame>Day 1</time_frame>
        <population>The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>CFZ533 + TAC + MMF (Part 1)</title>
            <description>CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Tmax Pharmacokinetic Parameter - Part I</title>
          <description>Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods.</description>
          <population>The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data.</population>
          <units>day</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.237" lower_limit="0" upper_limit="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean AUClast Pharmacokinetic Parameter - Part I</title>
        <description>Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods.</description>
        <time_frame>Day 1</time_frame>
        <population>The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>CFZ533 + TAC + MMF (Part 1)</title>
            <description>CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean AUClast Pharmacokinetic Parameter - Part I</title>
          <description>Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods.</description>
          <population>The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data.</population>
          <units>day*ug/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="367" spread="52.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Efficacy as Defined by the Frequency and Severity (Banff Classification) of Treated Biopsy Proven Acute Rejection (tBPAR) Adjudicated Data - Part II</title>
        <description>To assess the activity of the investigational arm as compared to the standard of care control arm in de novo renal transplant patients as measured by the frequency and severity of tBPAR as measured on the Banff classification scale.&#xD;
An adjudication was performed on all on cause renal biopsies by an independent expert committee blinded to therapy.</description>
        <time_frame>3, 6, 9, and 12 months</time_frame>
        <population>PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data.</population>
        <group_list>
          <group group_id="O1">
            <title>CFZ533 + MMF (Part 2)</title>
            <description>CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction</description>
          </group>
          <group group_id="O2">
            <title>Tac + MMF (Part 2)</title>
            <description>Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction]</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy as Defined by the Frequency and Severity (Banff Classification) of Treated Biopsy Proven Acute Rejection (tBPAR) Adjudicated Data - Part II</title>
          <description>To assess the activity of the investigational arm as compared to the standard of care control arm in de novo renal transplant patients as measured by the frequency and severity of tBPAR as measured on the Banff classification scale.&#xD;
An adjudication was performed on all on cause renal biopsies by an independent expert committee blinded to therapy.</description>
          <population>PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data.</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8976</p_value>
            <method>Bayesian posterior probability</method>
            <method_desc>Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is &lt; 20%.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.095</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.067</ci_lower_limit>
            <ci_upper_limit>0.263</ci_upper_limit>
            <estimate_desc>Month 3</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8836</p_value>
            <method>Bayesian posterior probability</method>
            <method_desc>Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is &lt; 20%.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.093</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.084</ci_lower_limit>
            <ci_upper_limit>0.271</ci_upper_limit>
            <estimate_desc>Month 6</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8822</p_value>
            <method>Bayesian posterior probability</method>
            <method_desc>Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is &lt; 20%.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.093</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.085</ci_lower_limit>
            <ci_upper_limit>0.272</ci_upper_limit>
            <estimate_desc>Month 9</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8821</p_value>
            <method>Bayesian posterior probability</method>
            <method_desc>Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is &lt; 20%.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.093</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.087</ci_lower_limit>
            <ci_upper_limit>0.273</ci_upper_limit>
            <estimate_desc>Month 12</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Soluble CD40 and Total Soluble CD154 Concentrations in Plasma - Part 1</title>
        <description>To quantify the change from baseline and recovery of peripheral blood total soluble CD40 and total soluble CD154</description>
        <time_frame>Baseline to end of study (Day 1, Day 29, Day 337)</time_frame>
        <population>PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data.</population>
        <group_list>
          <group group_id="O1">
            <title>sCD40 (Part I)</title>
            <description>CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).</description>
          </group>
          <group group_id="O2">
            <title>sCD154</title>
            <description>CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Soluble CD40 and Total Soluble CD154 Concentrations in Plasma - Part 1</title>
          <description>To quantify the change from baseline and recovery of peripheral blood total soluble CD40 and total soluble CD154</description>
          <population>PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data.</population>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.03" spread="4.08"/>
                    <measurement group_id="O2" value="0.125" spread="0.007"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.86" spread="0.0585"/>
                    <measurement group_id="O2" value="0.0585" spread="0.0711"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" spread="4.51"/>
                    <measurement group_id="O2" value="0.139" spread="0.193"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.8" spread="4.47"/>
                    <measurement group_id="O2" value="0.157" spread="0.235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.3" spread="6.34"/>
                    <measurement group_id="O2" value="0.241" spread="0.418"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.0" spread="11.2"/>
                    <measurement group_id="O2" value="0.399" spread="0.636"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.1" spread="13.8"/>
                    <measurement group_id="O2" value="0.0879" spread="0.139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102" spread="13.9"/>
                    <measurement group_id="O2" value="0.0500" spread="0.132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120" spread="15.7"/>
                    <measurement group_id="O2" value="0.225" spread="0.504"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128" spread="19.2"/>
                    <measurement group_id="O2" value="0.116" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145" spread="25.6"/>
                    <measurement group_id="O2" value="0.0193" spread="0.0474"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156" spread="6.35"/>
                    <measurement group_id="O2" value="0.0478" spread="0.0687"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161" spread="21.2"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163" spread="24.2"/>
                    <measurement group_id="O2" value="0.0316" spread="0.0492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156" spread="19.2"/>
                    <measurement group_id="O2" value="0.0148" spread="0.0363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168" spread="21.4"/>
                    <measurement group_id="O2" value="0.0139" spread="0.0340"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155" spread="23.3"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.7" spread="47.9"/>
                    <measurement group_id="O2" value="0.0668" spread="0.164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 127</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" spread="15.7"/>
                    <measurement group_id="O2" value="0.0488" spread="0.0697"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EoS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.918" spread="0.330"/>
                    <measurement group_id="O2" value="0.0184" spread="0.0411"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Free CD40 and Total CD40 on B Cells - Part II</title>
        <description>The magnitude and duration of peripheral blood CD40 occupancy. MESF: molecules of equivalent soluble fluorochrome</description>
        <time_frame>Baseline to end of study (Day 1/predose)</time_frame>
        <population>PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data.</population>
        <group_list>
          <group group_id="O1">
            <title>Free CD40 on Whole Blood B Ceels</title>
            <description>CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction</description>
          </group>
          <group group_id="O2">
            <title>Total CD40 on Whole Blood B Cells</title>
            <description>CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction</description>
          </group>
        </group_list>
        <measure>
          <title>Free CD40 and Total CD40 on B Cells - Part II</title>
          <description>The magnitude and duration of peripheral blood CD40 occupancy. MESF: molecules of equivalent soluble fluorochrome</description>
          <population>PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data.</population>
          <units>MESF</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CFZ553 + MMF (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30836.00" spread="13648.69"/>
                    <measurement group_id="O2" value="12778.80" spread="7873.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFZ553 + MMF (D1 - 6h post dose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1623.81" spread="1359.85"/>
                    <measurement group_id="O2" value="13806.90" spread="7185.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFZ553 + MMF (D15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="799.62" spread="762.38"/>
                    <measurement group_id="O2" value="15160.38" spread="7398.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFZ553 + MMF (D 29)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="817.63" spread="1540.16"/>
                    <measurement group_id="O2" value="13299.60" spread="6330.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFZ553 + MMF (D 57)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="597.13" spread="523.55"/>
                    <measurement group_id="O2" value="12234.38" spread="6943.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFZ553 + MMF (D 85)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="635.47" spread="614.68"/>
                    <measurement group_id="O2" value="9330.86" spread="8484.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFZ553 + MMF (D 197)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3699.0" spread="7298.98"/>
                    <measurement group_id="O2" value="2820.72" spread="2347.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFZ553 + MMF (253)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2667.38" spread="6146.86"/>
                    <measurement group_id="O2" value="1427.14" spread="740.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFZ553 + MMF (EoS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="176.17" spread="266.82"/>
                    <measurement group_id="O2" value="1069.67" spread="809.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tac + MMF (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31508.33" spread="12759.49"/>
                    <measurement group_id="O2" value="14581.43" spread="9342.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tac + MMF (D1 - 6h post dose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26437.65" spread="11930.50"/>
                    <measurement group_id="O2" value="13715.00" spread="8293.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tac + MMF (D15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24441.67" spread="9125.93"/>
                    <measurement group_id="O2" value="13707.14" spread="6770.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tac + MMF (D29)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27840.00" spread="12106.72"/>
                    <measurement group_id="O2" value="12698.75" spread="6002.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tac + MMF (D57)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27994.29" spread="12004.57"/>
                    <measurement group_id="O2" value="12583.85" spread="6210.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tac + MMF (D85)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25044.00" spread="10896.65"/>
                    <measurement group_id="O2" value="8701.54" spread="4183.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tac + MMF (D197)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21360.00" spread="3155.67"/>
                    <measurement group_id="O2" value="2067.60" spread="1617.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tac + MMF (D253)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15752.75" spread="7145.32"/>
                    <measurement group_id="O2" value="1750.50" spread="1005.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tac + MMF (EoS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21200.00" spread="4407.95"/>
                    <measurement group_id="O2" value="6276.17" spread="11271.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-CFZ533 Antibodies - Part I</title>
        <description>To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies</description>
        <time_frame>Baseline to end of study</time_frame>
        <population>Safety analysis set included all patients that received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>CFZ533 + TAC + MMF (Part 1)</title>
            <description>CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-CFZ533 Antibodies - Part I</title>
          <description>To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies</description>
          <population>Safety analysis set included all patients that received at least one dose of study drug.</population>
          <units>anti-CFZ533 antibodies</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-CFZ533 Antibodies - Part II</title>
        <description>To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies</description>
        <time_frame>Baseline to end of study (screening, baseline, Day 141, Day 225, Day 309, Study Completion)</time_frame>
        <population>Safety analysis set included all patients that received at least one dose of study drug. For Part 2, all patients that received their transplant along with any patient who received study drug but had no transplant were combined.</population>
        <group_list>
          <group group_id="O1">
            <title>CFZ533 + MMF (Part 2)</title>
            <description>CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction</description>
          </group>
          <group group_id="O2">
            <title>Tac + MMF (Part 2)</title>
            <description>Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction]</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-CFZ533 Antibodies - Part II</title>
          <description>To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies</description>
          <population>Safety analysis set included all patients that received at least one dose of study drug. For Part 2, all patients that received their transplant along with any patient who received study drug but had no transplant were combined.</population>
          <units>anti-CFZ533 antibodies</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screening</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 141</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 225</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 309</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study Completion</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>eGFR - Part II</title>
        <description>Renal function as assessed by MDRD (Modification of Diet in Renal Disease) formula.&#xD;
eGFR: Estimated glomerular filtration rate</description>
        <time_frame>Day 1, Day 29, Day 337,</time_frame>
        <population>Safety analysis set included all patients that received at least one dose of study drug. For Part 2, all patients that received their transplant along with any patient who received study drug but had no transplant were combined.</population>
        <group_list>
          <group group_id="O1">
            <title>CFZ533 + MMF (Part 2)</title>
            <description>CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction</description>
          </group>
          <group group_id="O2">
            <title>Tac + MMF (Part 2)</title>
            <description>Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction]</description>
          </group>
        </group_list>
        <measure>
          <title>eGFR - Part II</title>
          <description>Renal function as assessed by MDRD (Modification of Diet in Renal Disease) formula.&#xD;
eGFR: Estimated glomerular filtration rate</description>
          <population>Safety analysis set included all patients that received at least one dose of study drug. For Part 2, all patients that received their transplant along with any patient who received study drug but had no transplant were combined.</population>
          <units>ml/min</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" lower_limit="8.3" upper_limit="11.3"/>
                    <measurement group_id="O2" value="9.7" lower_limit="7.7" upper_limit="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6" lower_limit="50.4" upper_limit="60.7"/>
                    <measurement group_id="O2" value="44.3" lower_limit="37.2" upper_limit="51.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 337</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.2" lower_limit="52.2" upper_limit="64.2"/>
                    <measurement group_id="O2" value="44.2" lower_limit="36.1" upper_limit="52.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CFZ533 Plasma PK Concentrations - Part II</title>
        <description>Quantify the systemic concentrations of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods. A full pharmacokinetic analysis can be performed on the concentration-time data to evaluate the impact of renal transplantation on the various medications used in the treatment regimen.</description>
        <time_frame>throughout study period (day 84 to day 336)</time_frame>
        <population>The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>CFZ533 + MMF (Part 2)</title>
            <description>CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction</description>
          </group>
        </group_list>
        <measure>
          <title>CFZ533 Plasma PK Concentrations - Part II</title>
          <description>Quantify the systemic concentrations of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods. A full pharmacokinetic analysis can be performed on the concentration-time data to evaluate the impact of renal transplantation on the various medications used in the treatment regimen.</description>
          <population>The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data.</population>
          <units>ug/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="247" spread="58.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 112</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="211" spread="51.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 140</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="178" spread="54.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157" spread="57.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 196</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148" spread="53.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 224</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147" spread="53.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 252</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151" spread="35.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 280</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="160" spread="87.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 308</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="132" spread="42.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 336</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156" spread="85.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133" spread="57.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total sCD40 Plasma Concentrations - Part II</title>
        <description>To quantify the change from baseline and recovery of peripheral blood total soluble CD40</description>
        <time_frame>12 months</time_frame>
        <population>PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data.</population>
        <group_list>
          <group group_id="O1">
            <title>CFZ533 + MMF (Part 2)</title>
            <description>CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction</description>
          </group>
          <group group_id="O2">
            <title>Tac + MMF (Part 2)</title>
            <description>Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction]</description>
          </group>
        </group_list>
        <measure>
          <title>Total sCD40 Plasma Concentrations - Part II</title>
          <description>To quantify the change from baseline and recovery of peripheral blood total soluble CD40</description>
          <population>PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.02" spread="2.44"/>
                    <measurement group_id="O2" value="3.67" spread="2.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.95" spread="4.29"/>
                    <measurement group_id="O2" value="1.16" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6" spread="11.0"/>
                    <measurement group_id="O2" value="1.16" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.6" spread="21.5"/>
                    <measurement group_id="O2" value="0.869" spread="1.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101" spread="18.9"/>
                    <measurement group_id="O2" value="0.362" spread="0.0746"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140" spread="17.4"/>
                    <measurement group_id="O2" value="0.438" spread="0.316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="189" spread="76.4"/>
                    <measurement group_id="O2" value="0.429" spread="0.324"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="215" spread="75.5"/>
                    <measurement group_id="O2" value="0.391" spread="0.129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 141</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="237" spread="93.1"/>
                    <measurement group_id="O2" value="0.453" spread="0.271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="238" spread="80.3"/>
                    <measurement group_id="O2" value="0.537" spread="0.215"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="253" spread="81.3"/>
                    <measurement group_id="O2" value="0.423" spread="0.0908"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 225</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="258" spread="77.7"/>
                    <measurement group_id="O2" value="0.452" spread="0.119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 253</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="236" spread="36.5"/>
                    <measurement group_id="O2" value="0.457" spread="0.0800"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 281</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="273" spread="71.3"/>
                    <measurement group_id="O2" value="0.455" spread="0.0789"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 309</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="286" spread="66.0"/>
                    <measurement group_id="O2" value="0.454" spread="0.0957"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 337</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="298" spread="57.4"/>
                    <measurement group_id="O2" value="0.411" spread="0.0581"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="303" spread="59.7"/>
                    <measurement group_id="O2" value="0.959" spread="1.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 3 years.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CFZ533 + TAC + MMF (Part 1)</title>
          <description>CFZ533 (3 mg/kg SC) administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).</description>
        </group>
        <group group_id="E2">
          <title>CFZ533 + MMF (Part 2)</title>
          <description>CFZ533 (10mg/kg IV) administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction</description>
        </group>
        <group group_id="E3">
          <title>Tac + MMF (Part 2)</title>
          <description>Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction]</description>
        </group>
        <group group_id="E4">
          <title>Total</title>
          <description>Total</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="37" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </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="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Tricuspid valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Diarrhoea haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastrointestinal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Kidney transplant rejection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Transplant rejection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Enterobacter bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hepatitis C</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Polyomavirus-associated nephropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Renal cyst infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Complications of transplanted kidney</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Delayed graft function</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Graft loss</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Incarcerated incisional hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Incisional hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Transplant dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Transplant failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basosquamous carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </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="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Renal tubular necrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </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="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Lymphocele</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pelvic venous thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="58" subjects_at_risk="59"/>
              </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="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Microcytic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Nephrogenic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Normocytic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Polycythaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Tricuspid valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Hydrocele</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperparathyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hyperparathyroidism secondary</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Chalazion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Eye movement disorder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Retinal vein occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Anal fissure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="23" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Duodenogastric reflux</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastric polyps</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastritis haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gingival recession</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gingival swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="23" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Tongue discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Infusion site swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Secretion discharge</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hepatomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Kidney transplant rejection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>BK virus infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus viraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Diarrhoea infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Epstein-Barr virus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastroenteritis Escherichia coli</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastroenteritis norovirus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Human polyomavirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Latent tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Mucocutaneous candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Oral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Polyomavirus-associated nephropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pyuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Tinea versicolour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Urinary tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Wound infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Arterial injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula site complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Complications of transplant surgery</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Complications of transplanted kidney</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Delayed graft function</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Graft complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Incision site complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Incision site erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Incision site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Incision site pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Incisional hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Lip injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Post procedural swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Postoperative wound complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Seroma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Transplant dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Wound complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Wound haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Blood phosphorus decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Blood phosphorus increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Drug level decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Electrocardiogram ST segment abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Electrocardiogram T wave abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Heart rate irregular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Polyomavirus test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Vitamin D decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </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="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Folate deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hyperphosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypervolaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="21" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Magnesium deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </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="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypercreatinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Joint effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Osteochondrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Peroneal nerve palsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Polyneuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Mood swings</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Phonophobia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Bladder pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Bladder spasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Leukocyturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Perinephric collection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Perinephric oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Renal tubular acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Renal tubular injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Renal tubular necrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Sterile pyuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Urethral pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Urinary tract disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Penile oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Penile pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Prostatomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Scrotal swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </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="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Lung infiltration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Lipohypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pityriasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Lymphocele</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Poor venous access</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>862-778-8300</phone>
      <email>Novartis.email@novartis.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/NCT02217410
org study id: CCFZ533X2201
nct id: NCT02217410
lead sponsor: 
has dmc: Yes
The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK)
      and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar
      rate of acute rejection prophylaxis and renal function in a de novo renal transplant
      population receiving an allograft from standard criteria donors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Mean Cmax Pharmacokinetic Parameter- Part I
time frame: Day 1
description: Pharmacokinetics as defined by the systemic concentrations and Cmax of certain immunosuppressant medications used in Part I
measure: Mean Tmax Pharmacokinetic Parameter - Part I
time frame: Day 1
description: Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods.
measure: Mean AUClast Pharmacokinetic Parameter - Part I
time frame: Day 1
description: Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods.
measure: Efficacy as Defined by the Frequency and Severity (Banff Classification) of Treated Biopsy Proven Acute Rejection (tBPAR) Adjudicated Data - Part II
time frame: 3, 6, 9, and 12 months
description: To assess the activity of the investigational arm as compared to the standard of care control arm in de novo renal transplant patients as measured by the frequency and severity of tBPAR as measured on the Banff classification scale.
An adjudication was performed on all on cause renal biopsies by an independent expert committee blinded to therapy.
measure: Total Soluble CD40 and Total Soluble CD154 Concentrations in Plasma - Part 1
time frame: Baseline to end of study (Day 1, Day 29, Day 337)
description: To quantify the change from baseline and recovery of peripheral blood total soluble CD40 and total soluble CD154
measure: Free CD40 and Total CD40 on B Cells - Part II
time frame: Baseline to end of study (Day 1/predose)
description: The magnitude and duration of peripheral blood CD40 occupancy. MESF: molecules of equivalent soluble fluorochrome
measure: Anti-CFZ533 Antibodies - Part I
time frame: Baseline to end of study
description: To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies
measure: Anti-CFZ533 Antibodies - Part II
time frame: Baseline to end of study (screening, baseline, Day 141, Day 225, Day 309, Study Completion)
description: To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies
measure: eGFR - Part II
time frame: Day 1, Day 29, Day 337,
description: Renal function as assessed by MDRD (Modification of Diet in Renal Disease) formula.
eGFR: Estimated glomerular filtration rate
measure: CFZ533 Plasma PK Concentrations - Part II
time frame: throughout study period (day 84 to day 336)
description: Quantify the systemic concentrations of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods. A full pharmacokinetic analysis can be performed on the concentration-time data to evaluate the impact of renal transplantation on the various medications used in the treatment regimen.
measure: Total sCD40 Plasma Concentrations - Part II
time frame: 12 months
description: To quantify the change from baseline and recovery of peripheral blood total soluble CD40
arm group label: Regimen A
arm group type: Experimental
description: CFZ533 administered with the contemporary standard of care (SoC) consists of concentration-controlled tacrolimus (Tac), combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
arm group label: Regimen B
arm group type: Experimental
description: CFZ533 administered with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction
arm group label: Regimen C
arm group type: Active Comparator
description: Standard of care (SoC) [concentration-controlled tacrolimus (Tac) combined with mycophenolate mofetil (MMF) and corticosteroids (CS) with anti-IL2 induction]
intervention type: Biological
intervention name: CFZ533
arm group label: Regimen A
arm group label: Regimen B
intervention type: Drug
intervention name: Tacrolimus (Tac)
arm group label: Regimen A
arm group label: Regimen C
intervention type: Drug
intervention name: Mycophenolate mofetil (MMF)
arm group label: Regimen A
arm group label: Regimen B
arm group label: Regimen C
intervention type: Drug
intervention name: Corticosteroids (CS)
arm group label: Regimen A
arm group label: Regimen B
arm group label: Regimen C
intervention type: Biological
intervention name: anti-IL2 Induction
arm group label: Regimen B
arm group label: Regimen C
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
country: Germany
country: Netherlands
country: United States
url: https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=420
description: Plain Language Trial Summary is available on novartisclinicaltrials.com
responsible party type: Sponsor
mesh term: Mycophenolic Acid
mesh term: Tacrolimus
sharing ipd: Undecided
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 