<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/NCT01693029</url>
  </required_header>
  <id_info>
    <org_study_id>HX575-307</org_study_id>
    <nct_id>NCT01693029</nct_id>
  </id_info>
  <brief_title>Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa</brief_title>
  <acronym>ACCESS</acronym>
  <official_title>Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of HX575 Epoetin Alfa vs. US Licensed Epoetin Alfa (Epogen®/Procrit®) in the Treatment of Anemia Associated With Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sandoz</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sandoz</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed&#xD;
      reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to&#xD;
      generate data supporting that the efficacy and safety under treatment with HX575 and&#xD;
      Epogen®/Procrit® are comparable.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, parallel-group, multicenter study to evaluate the&#xD;
      efficacy and safety of HX575 epoetin alfa vs. US-licensed epoetin alfa (Epogen®/Procrit®) in&#xD;
      the treatment of anemia associated with chronic kidney disease (CKD).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)</measure>
    <time_frame>Week -4 to Day1 and Week 21-28</time_frame>
    <description>Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28)</measure>
    <time_frame>Week -4 to Day1 and Week 21-28</time_frame>
    <description>Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Weekly Dose During Evaluation Period (Week 21-28)</measure>
    <time_frame>Week 21-28</time_frame>
    <description>Mean weekly study drug dose during evaluation period (Week 21-28)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Antibody Formation Against Epoetin</measure>
    <time_frame>52 weeks</time_frame>
    <description>Number of patients with positive antidrug antibody (ADA) finding at any time during their treatment period. Count includes 2 patients (1 in each arm) that already had a positive ADA Baseline finding. ADA testing performed by by Radio-Immuno-Precipitation assay. No patient developed neutralizing antibodies.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">435</enrollment>
  <condition>Anemia</condition>
  <condition>Chronic Kidney Disease (CKD)</condition>
  <arm_group>
    <arm_group_label>HX575 epoetin alfa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HX575, recombinant human epoetin alfa</description>
  </arm_group>
  <arm_group>
    <arm_group_label>US-licensed epoetin alfa</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>US-licensed recombinant human epoetin alfa</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HX575 epoetin alfa</intervention_name>
    <description>Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.</description>
    <arm_group_label>HX575 epoetin alfa</arm_group_label>
    <other_name>Binocrit® (Europe)</other_name>
    <other_name>Epoetin alfa HEXAL® (Europe)</other_name>
    <other_name>Abseamed® (Europe)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>US-licensed epoetin alfa</intervention_name>
    <description>Solution for subcutaneous injection.</description>
    <arm_group_label>US-licensed epoetin alfa</arm_group_label>
    <other_name>Epogen®</other_name>
    <other_name>Procrit®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with end stage renal disease (stage CKD 5d), receiving stable subcutaneous&#xD;
             maintenance therapy with Epogen® or Procrit® at least once per week&#xD;
&#xD;
          -  Mean hemoglobin level between 9.0 - 11.5 g/dL during the screening period&#xD;
&#xD;
          -  Adequate iron substitution&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for Erythropoiesis Stimulating Agent (ESA) therapy&#xD;
&#xD;
          -  History of Pure Red Cell Aplasia (PRCA), or anti-erythropoietin (EPO) antibodies&#xD;
&#xD;
          -  Known Human Immunodeficiency Virus (HIV) or Hepatitis B infection&#xD;
&#xD;
          -  Hepatitis C infection on an active treatment&#xD;
&#xD;
          -  Symptomatic congestive heart failure (New York Heart Association [NYHA] class III and&#xD;
             IV)&#xD;
&#xD;
          -  Unstable angina pectoris, or cardiac infarction during the last 6 months prior to&#xD;
             randomization&#xD;
&#xD;
          -  Percutaneous coronary intervention, or coronary artery bypass grafting during the last&#xD;
             6 months prior to randomization&#xD;
&#xD;
          -  History of malignancy of any organ system&#xD;
&#xD;
          -  Systemic lupus erythematous&#xD;
&#xD;
          -  Immunocompromized patients&#xD;
&#xD;
        Other In-/Exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandoz Biopharmaceutical Clinical Development</last_name>
    <role>Study Director</role>
    <affiliation>Sandoz Biopharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southwestern Kidney Institute</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85284</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North America Research Institute</name>
      <address>
        <city>Azusa</city>
        <state>California</state>
        <zip>91702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pegasus Dialysis, LLC</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Nephrology Medical Group</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Institute of Renal Research</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renal Consultants Medical Group</name>
      <address>
        <city>Granada Hills</city>
        <state>California</state>
        <zip>91344</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Angel Kidney Care of Inglewood Dialysis Center</name>
      <address>
        <city>Inglewood</city>
        <state>California</state>
        <zip>90301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Institute of Renal Research</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Research Centers</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Medical Research Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ronald Reagan Medical Center, Department of Pharmaceutical Services, Drug Information Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tower Nephrology Medical Group</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent Dialysis Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kidney Research Center</name>
      <address>
        <city>Lynwood</city>
        <state>California</state>
        <zip>90262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Renal Medical Group</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ontario Dialysis, Inc.</name>
      <address>
        <city>Ontario</city>
        <state>California</state>
        <zip>91762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apex Research of Riverside</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capital Nephrology Medical Group</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Institute of Renal Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>La Jolla Clinical Research, Inc.</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North America Research Institute</name>
      <address>
        <city>San Dimas</city>
        <state>California</state>
        <zip>91773</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Institute of Research</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Nephrology</name>
      <address>
        <city>Coral Springs</city>
        <state>Florida</state>
        <zip>33071</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pines Clinical Research Inc.</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesis Clinical Research Corporation</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atekha Nephrology Clinic LLC</name>
      <address>
        <city>Statesboro</city>
        <state>Georgia</state>
        <zip>30458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Four Rivers Clinical Research, Incorporated</name>
      <address>
        <city>Paducah</city>
        <state>Kentucky</state>
        <zip>42003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Louisana Nephrology</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Germantown Dialysis</name>
      <address>
        <city>Germantown</city>
        <state>Maryland</state>
        <zip>20874</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fresenius Management Services, Inc.</name>
      <address>
        <city>Farmington</city>
        <state>Missouri</state>
        <zip>63640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Creighton University</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kidney Specialists of Southern Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seacoast Kidney and Hypertension Specialist, PLLC</name>
      <address>
        <city>Portsmouth</city>
        <state>New Hampshire</state>
        <zip>03801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renal Medicine Associates</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Hospital Queens</name>
      <address>
        <city>Fresh Meadows</city>
        <state>New York</state>
        <zip>11365</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metrolina Nephrology Associates, PA</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boice-Willis Clinic, PA</name>
      <address>
        <city>Rocky Mount</city>
        <state>North Carolina</state>
        <zip>27804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Dialysis Center</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Clinical Research Centers, Inc.</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delaware Valley Nephrology and Hypertension Associates, PC</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palmetto Nephrology PA</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Nephrology &amp; Hypertension Center, Inc.</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Knoxville Kidney Center PLLC</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37923</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Management, Inc.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gamma Clinical Research Institute</name>
      <address>
        <city>Edinburg</city>
        <state>Texas</state>
        <zip>78539</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nephrology, P.A.</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Network</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renal Associates, PA</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215-2035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Utah Kidney and Hypertension Center</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mendez Center For Clinical Research, LLC</name>
      <address>
        <city>Alexandria</city>
        <state>Virginia</state>
        <zip>22304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Hospitals and Clinic</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <results_first_submitted>April 4, 2017</results_first_submitted>
  <results_first_submitted_qc>April 4, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 12, 2017</results_first_posted>
  <disposition_first_submitted>May 4, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>May 4, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">May 20, 2015</disposition_first_posted>
  <last_update_submitted>June 1, 2017</last_update_submitted>
  <last_update_submitted_qc>June 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>erythropoietin alfa</keyword>
  <keyword>CKD 5d</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epoetin Alfa</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>HX575 Epoetin Alfa</title>
          <description>HX575, recombinant human epoetin alfa&#xD;
HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.</description>
        </group>
        <group group_id="P2">
          <title>US-licensed Epoetin Alfa</title>
          <description>US-licensed recombinant human epoetin alfa&#xD;
US-licensed epoetin alfa: Solution for subcutaneous injection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="217"/>
                <participants group_id="P2" count="218"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="173"/>
                <participants group_id="P2" count="161"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Kidney transplantation</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Bindinging anti-EPO antibodies</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Change in dialysis modality</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>HX575 Epoetin Alfa</title>
          <description>HX575, recombinant human epoetin alfa&#xD;
HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.</description>
        </group>
        <group group_id="B2">
          <title>US-licensed Epoetin Alfa</title>
          <description>US-licensed recombinant human epoetin alfa&#xD;
US-licensed epoetin alfa: Solution for subcutaneous injection.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="217"/>
            <count group_id="B2" value="218"/>
            <count group_id="B3" value="435"/>
          </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="59.8" spread="13.76"/>
                    <measurement group_id="B2" value="57.6" spread="13.40"/>
                    <measurement group_id="B3" value="58.7" spread="13.61"/>
                  </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="82"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="185"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="135"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="250"/>
                  </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="95"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="188"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                    <measurement group_id="B2" value="125"/>
                    <measurement group_id="B3" value="247"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="129"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="139"/>
                    <measurement group_id="B2" value="128"/>
                    <measurement group_id="B3" value="267"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="217"/>
                    <measurement group_id="B2" value="218"/>
                    <measurement group_id="B3" value="435"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="167.2" spread="10.17"/>
                    <measurement group_id="B2" value="166.0" spread="10.33"/>
                    <measurement group_id="B3" value="166.6" spread="10.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82.8" spread="20.75"/>
                    <measurement group_id="B2" value="86.5" spread="24.32"/>
                    <measurement group_id="B3" value="84.6" spread="22.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.55" spread="6.872"/>
                    <measurement group_id="B2" value="31.41" spread="8.783"/>
                    <measurement group_id="B3" value="30.48" spread="7.933"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary cause of Chronic Kidney Disease (CKD)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Diabetes mellitus</title>
                  <measurement_list>
                    <measurement group_id="B1" value="115"/>
                    <measurement group_id="B2" value="122"/>
                    <measurement group_id="B3" value="237"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hypertension</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Chronic glomerulonephritis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Kidney abnormalities</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Polycystic kidney disease</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Urinary tract obstruction</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Vasculitis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Amyloidosis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of last Erythropoiesis Stimulating Agent (ESA) therapy prior</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Epogen</title>
                  <measurement_list>
                    <measurement group_id="B1" value="217"/>
                    <measurement group_id="B2" value="215"/>
                    <measurement group_id="B3" value="432"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Procrit</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time since start of ESA therapy</title>
          <units>months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.59" lower_limit="13.01" upper_limit="54.01"/>
                    <measurement group_id="B2" value="36.24" lower_limit="17.15" upper_limit="62.09"/>
                    <measurement group_id="B3" value="32.95" lower_limit="14.85" upper_limit="59.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time since start of dialysis</title>
          <units>months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.11" lower_limit="18.53" upper_limit="66.40"/>
                    <measurement group_id="B2" value="41.08" lower_limit="22.54" upper_limit="63.64"/>
                    <measurement group_id="B3" value="38.60" lower_limit="20.93" upper_limit="64.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Method of dialysis at Baseline</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hemodialysis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="192"/>
                    <measurement group_id="B2" value="192"/>
                    <measurement group_id="B3" value="384"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Peritoneal dialysis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)</title>
        <description>Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .</description>
        <time_frame>Week -4 to Day1 and Week 21-28</time_frame>
        <population>The intent-to-treat (ITT) population consists of all randomized patients who were exposed to treatment with study drug for at least four weeks and have at least one Hb value available at week 4 or later. Following the intent-to-treat principle, patients are analyzed according to the treatment they were assigned to at randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>HX575 Epoetin Alfa</title>
            <description>HX575, recombinant human epoetin alfa&#xD;
HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.</description>
          </group>
          <group group_id="O2">
            <title>US-licensed Epoetin Alfa</title>
            <description>US-licensed recombinant human epoetin alfa&#xD;
US-licensed epoetin alfa: Solution for subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)</title>
          <description>Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .</description>
          <population>The intent-to-treat (ITT) population consists of all randomized patients who were exposed to treatment with study drug for at least four weeks and have at least one Hb value available at week 4 or later. Following the intent-to-treat principle, patients are analyzed according to the treatment they were assigned to at randomization.</population>
          <units>g/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="212"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0960" spread="0.0575"/>
                    <measurement group_id="O2" value="-0.0035" spread="0.0573"/>
                  </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>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence margin (-0.5, 0.5) g/dL. Results from ANCOVA with factors &quot;treatment group&quot; and covariates mean baseline Hb and mean weekly dose during the evaluation period (Week 21-28)</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0926</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2264</ci_lower_limit>
            <ci_upper_limit>0.0413</ci_upper_limit>
            <other_analysis_desc>95% confidence interval for the difference is (-0.2522, 0.0670).</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28)</title>
        <description>Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .</description>
        <time_frame>Week -4 to Day1 and Week 21-28</time_frame>
        <population>The intent-to-treat (ITT) population consists of all randomized patients who were exposed to treatment with study drug for at least four weeks and have at least one Hb value available at week 4 or later. Following the intent-to-treat principle, patients are analyzed according to the treatment they were assigned to at randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>HX575 Epoetin Alfa</title>
            <description>HX575, recombinant human epoetin alfa&#xD;
HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.</description>
          </group>
          <group group_id="O2">
            <title>US-licensed Epoetin Alfa</title>
            <description>US-licensed recombinant human epoetin alfa&#xD;
US-licensed epoetin alfa: Solution for subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28)</title>
          <description>Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .</description>
          <population>The intent-to-treat (ITT) population consists of all randomized patients who were exposed to treatment with study drug for at least four weeks and have at least one Hb value available at week 4 or later. Following the intent-to-treat principle, patients are analyzed according to the treatment they were assigned to at randomization.</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="212"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline period</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.53" spread="0.635"/>
                    <measurement group_id="O2" value="10.50" spread="0.615"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Evaluation period</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.42" spread="0.826"/>
                    <measurement group_id="O2" value="10.51" spread="0.873"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline period to evaluation period</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="1.011"/>
                    <measurement group_id="O2" value="0.01" spread="0.953"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Weekly Dose During Evaluation Period (Week 21-28)</title>
        <description>Mean weekly study drug dose during evaluation period (Week 21-28)</description>
        <time_frame>Week 21-28</time_frame>
        <population>The intent-to-treat (ITT) population consists of all randomized patients who were exposed to treatment with study drug for at least four weeks and have at least one Hb value available at week 4 or later. Following the intent-to-treat principle, patients are analyzed according to the treatment they were assigned to at randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>HX575 Epoetin Alfa</title>
            <description>HX575, recombinant human epoetin alfa&#xD;
HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.</description>
          </group>
          <group group_id="O2">
            <title>US-licensed Epoetin Alfa</title>
            <description>US-licensed recombinant human epoetin alfa&#xD;
US-licensed epoetin alfa: Solution for subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Weekly Dose During Evaluation Period (Week 21-28)</title>
          <description>Mean weekly study drug dose during evaluation period (Week 21-28)</description>
          <population>The intent-to-treat (ITT) population consists of all randomized patients who were exposed to treatment with study drug for at least four weeks and have at least one Hb value available at week 4 or later. Following the intent-to-treat principle, patients are analyzed according to the treatment they were assigned to at randomization.</population>
          <units>international units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="212"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5876.5" spread="5785.50"/>
                    <measurement group_id="O2" value="5804.0" spread="6343.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Antibody Formation Against Epoetin</title>
        <description>Number of patients with positive antidrug antibody (ADA) finding at any time during their treatment period. Count includes 2 patients (1 in each arm) that already had a positive ADA Baseline finding. ADA testing performed by by Radio-Immuno-Precipitation assay. No patient developed neutralizing antibodies.</description>
        <time_frame>52 weeks</time_frame>
        <population>All patients treated with study drug with a post-baseline antibody assessment</population>
        <group_list>
          <group group_id="O1">
            <title>HX575 Epoetin Alfa</title>
            <description>HX575, recombinant human epoetin alfa&#xD;
HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.</description>
          </group>
          <group group_id="O2">
            <title>US-licensed Epoetin Alfa</title>
            <description>US-licensed recombinant human epoetin alfa&#xD;
US-licensed epoetin alfa: Solution for subcutaneous injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Antibody Formation Against Epoetin</title>
          <description>Number of patients with positive antidrug antibody (ADA) finding at any time during their treatment period. Count includes 2 patients (1 in each arm) that already had a positive ADA Baseline finding. ADA testing performed by by Radio-Immuno-Precipitation assay. No patient developed neutralizing antibodies.</description>
          <population>All patients treated with study drug with a post-baseline antibody assessment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the date of informed consent until the end of the treatment period, for approximately 1 year.</time_frame>
      <desc>Adverse events recorded before first study drug were considered pre-treatment adverse events, adverse events recorded more than 30 days after last study drug treatment were considered post-treatment emergent adverse event. Only treatment-emergent adverse events are shown in adverse events counts.</desc>
      <group_list>
        <group group_id="E1">
          <title>HX575 Epoetin Alfa</title>
          <description>HX575, recombinant human epoetin alfa&#xD;
HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.</description>
        </group>
        <group group_id="E2">
          <title>US-licensed Epoetin Alfa</title>
          <description>US-licensed recombinant human epoetin alfa&#xD;
US-licensed epoetin alfa: Solution for subcutaneous injection.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="91" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="90" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="217"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="217"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="217"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="217"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Cardiovascular deconditioning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperparathyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Diabetic gastroparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Erosive oesophagitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Large intestinal ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Medical device complication</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="217"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="217"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="217"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="217"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="217"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Streptococcal bacteraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Lobar pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Arteriovenous graft site infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Abscess neck</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Intervertebral discitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Salmonellosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Urinary tract infection enterococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula thrombosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula site complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Procedural complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Skin injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Ulna fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Arteriovenous graft aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Incision site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Procedural hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Pubis fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="217"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="217"/>
                <counts group_id="E2" events="13" subjects_affected="8" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="217"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Cachexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Lactic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Renal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Endometrial cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Myoclonus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Speech disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure chronic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Renal mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Azotaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </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" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Postmenopausal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="217"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Lung infiltration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Dry gangrene</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Treatment noncompliance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Biliary tract dilation procedure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Extremity necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Malignant hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Accelerated hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="112" subjects_at_risk="217"/>
                <counts group_id="E2" subjects_affected="123" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="26" subjects_affected="21" subjects_at_risk="217"/>
                <counts group_id="E2" events="24" subjects_affected="19" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="20" subjects_affected="17" subjects_at_risk="217"/>
                <counts group_id="E2" events="23" subjects_affected="20" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="18" subjects_affected="10" subjects_at_risk="217"/>
                <counts group_id="E2" events="18" subjects_affected="15" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="217"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="16" subjects_affected="12" subjects_at_risk="217"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="217"/>
                <counts group_id="E2" events="24" subjects_affected="22" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="15" subjects_affected="12" subjects_at_risk="217"/>
                <counts group_id="E2" events="13" subjects_affected="10" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="20" subjects_affected="13" subjects_at_risk="217"/>
                <counts group_id="E2" events="31" subjects_affected="18" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula site complication</sub_title>
                <counts group_id="E1" events="17" subjects_affected="15" subjects_at_risk="217"/>
                <counts group_id="E2" events="16" subjects_affected="11" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="217"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="217"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="16" subjects_affected="12" subjects_at_risk="217"/>
                <counts group_id="E2" events="18" subjects_affected="16" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="217"/>
                <counts group_id="E2" events="15" subjects_affected="13" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="217"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="17" subjects_affected="15" subjects_at_risk="217"/>
                <counts group_id="E2" events="18" subjects_affected="15" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="217"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="217"/>
                <counts group_id="E2" events="18" subjects_affected="15" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="40" subjects_affected="24" subjects_at_risk="217"/>
                <counts group_id="E2" events="34" subjects_affected="27" subjects_at_risk="218"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="217"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="218"/>
              </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 Sponsor shall have the right to the first publication or presentation of the results of the study which is intended to be a joint, multi-center publication of the study results. Following the first publication, institutions and/or Principal Investigators may publish or present data or results from the study per the terms of the clinical trial agreement.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Biopharmaceutical Clinical Development, Strategic Planning</name_or_title>
      <organization>Sandoz</organization>
      <phone>004980244760</phone>
      <email>biopharma.clinicaltrials@sandoz.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/NCT01693029
org study id: HX575-307
nct id: NCT01693029
lead sponsor: 
has dmc: Yes
The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed
      reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to
      generate data supporting that the efficacy and safety under treatment with HX575 and
      Epogen®/Procrit® are comparable.
This is a randomized, double-blind, parallel-group, multicenter study to evaluate the
      efficacy and safety of HX575 epoetin alfa vs. US-licensed epoetin alfa (Epogen®/Procrit®) in
      the treatment of anemia associated with chronic kidney disease (CKD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)
time frame: Week -4 to Day1 and Week 21-28
description: Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
measure: Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28)
time frame: Week -4 to Day1 and Week 21-28
description: Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
measure: Mean Weekly Dose During Evaluation Period (Week 21-28)
time frame: Week 21-28
description: Mean weekly study drug dose during evaluation period (Week 21-28)
measure: Incidence of Antibody Formation Against Epoetin
time frame: 52 weeks
description: Number of patients with positive antidrug antibody (ADA) finding at any time during their treatment period. Count includes 2 patients (1 in each arm) that already had a positive ADA Baseline finding. ADA testing performed by by Radio-Immuno-Precipitation assay. No patient developed neutralizing antibodies.
arm group label: HX575 epoetin alfa
arm group type: Experimental
description: HX575, recombinant human epoetin alfa
arm group label: US-licensed epoetin alfa
arm group type: Active Comparator
description: US-licensed recombinant human epoetin alfa
intervention type: Drug
intervention name: HX575 epoetin alfa
description: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.
arm group label: HX575 epoetin alfa
other name: Binocrit® (Europe)
other name: Epoetin alfa HEXAL® (Europe)
other name: Abseamed® (Europe)
intervention type: Drug
intervention name: US-licensed epoetin alfa
description: Solution for subcutaneous injection.
arm group label: US-licensed epoetin alfa
other name: Epogen®
other name: Procrit®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sandoz Biopharmaceutical Clinical Development
role: Study Director
affiliation: Sandoz Biopharmaceuticals
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country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Anemia
mesh term: Epoetin Alfa
sharing ipd: Undecided
participant flow: 
baseline: 
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reported events: 
certain agreements: 
point of contact: 