<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/NCT03033745</url>
  </required_header>
  <id_info>
    <org_study_id>IgPro20_4004</org_study_id>
    <secondary_id>2016-003799-33</secondary_id>
    <nct_id>NCT03033745</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID)</brief_title>
  <official_title>An Open-label Multicenter Study to Evaluate the Safety and Tolerability of Higher Infusion Parameters of Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra®) in Subjects With Primary Immunodeficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSL Behring</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CSL Behring</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multicenter, open-label, parallel-arm, non-randomized study is designed to evaluate&#xD;
      safety and tolerability of higher infusion parameters of IgPro20 in subjects with primary&#xD;
      immunodeficiency (PID). A total of 45 subjects (including at least 14 [30%] pediatric&#xD;
      subjects ≤ 17 years of age and at least 9 [20%] obese subjects with body mass index [BMI] of&#xD;
      ≥30 kg/m2) with confirmed PID will be evaluated in the study. The study will include three&#xD;
      cohorts of 15 subjects each as follows: i) Pump-Assisted Volume Cohort (weekly infusions),&#xD;
      volume per injection site of 25 mL up to 50 mL, ii) Pump Assisted Flow Rate Cohort (weekly&#xD;
      infusions), flow rate per injection site of 25 mL/hour up to 100 mL/hour, iii) Manual Push&#xD;
      Flow Rate Cohort (2 to 7 infusions per week), flow rate per injection site of 25 to 30&#xD;
      mL/hour up to 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute). Each&#xD;
      cohort will test 3 infusion parameter levels (4 for the pump-assisted flow rate cohort),&#xD;
      repeated at least 4 times over a duration of 12 weeks (16 weeks for the flow rate cohort).&#xD;
      After 4 infusion weeks at each level, qualifying subjects (responders) will switch to the&#xD;
      next infusion parameter level (eg, from 25 to 50 mL/h). During the study, the weekly dose&#xD;
      will remain unchanged (as prescribed by treating physician, usually within 100-200 mg/kg per&#xD;
      week range); only the respective infusion parameter under evaluation will change.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">December 14, 2018</completion_date>
  <primary_completion_date type="Actual">December 14, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Responders</measure>
    <time_frame>At the end of 4 weeks for each planned infusion parameter</time_frame>
    <description>A responder is a subject within the Pump-Assisted Cohorts that performs at least 3 out of 4 valid infusions at a certain infusion parameter level (weekly volumes per injection site of 25-50 mL; weekly flow rates per injection site of 25-100 mL/hour). Determination of a responder in the Manual Push Cohort is more complex due to the expected variable frequency of infusions per week (ie, 5-17) for different subjects. A responder within the Manual Push Cohort is a subject that performs a minimum number of valid infusions during 4 weeks corresponding to a certain flow rate level ([ie, 2-7 times per week], flow rates per injection site of 30-120 mL/hour). Valid infusions do not need to be consecutive, but each subject needs to adhere to the same schedule (number of infusions per week) throughout the study. An infusion parameter will be considered successful if at least one third (≥ 33%) of the subjects in the corresponding cohort are responders at that infusion parameter level.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion</measure>
    <time_frame>At the end of 4 weeks for each planned infusion parameter</time_frame>
    <description>Adverse event rate per infusion = number of adverse events/total number of infusions prior to subject's start date of non-response. Only events are included which start prior to subject's start date of non-response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Local TEAEs Per Infusion</measure>
    <time_frame>At the end of 4 weeks for each planned infusion parameter</time_frame>
    <description>Local adverse event rate per infusion = number of local adverse events/total number of infusions prior to subject's start date of non-response. Local Adverse Events: comprises all events reported within the MedDRA high level terms &quot;administration site reactions NEC (Not Elsewhere Classified)&quot;, &quot;infusion site reactions&quot;, and &quot;injection site reactions&quot;. Only events are included which start prior to subject's start date of non-response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Onset of Local TEAEs</measure>
    <time_frame>At the end of 4 weeks for each planned infusion parameter</time_frame>
    <description>Local Adverse Events: comprises all events reported within the MedDRA high level terms &quot;administration site reactions NEC&quot;, &quot;infusion site reactions&quot;, and &quot;injection site reactions&quot;. Only events are included which start prior to subject's start date of non-response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of Local TEAEs</measure>
    <time_frame>At the end of 4 weeks for each planned infusion parameter</time_frame>
    <description>Mild = A type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate = A type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the subject. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Local TEAEs</measure>
    <time_frame>At the end of 4 weeks for each planned infusion parameter</time_frame>
    <description>Local Adverse Events: comprises all events reported within the MedDRA high level terms &quot;administration site reactions NEC&quot;, &quot;infusion site reactions&quot;, and &quot;injection site reactions&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability of Infusions</measure>
    <time_frame>At the end of 4 weeks for each planned infusion parameter</time_frame>
    <description>Tolerability = number of infusions without severe local adverse events / total number of infusions. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Primary Immunodeficiency</condition>
  <arm_group>
    <arm_group_label>IgPro20 (Pump-Assisted Volume Cohort)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly volumes per injection site of 25 mL up to 50 mL administered subcutaneously.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IgPro20 (Pump Assisted Flow Rate Cohort)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IgPro20 (Manual Push Flow Rate Cohort)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Frequent (ie, 2 to 7 times per week) flow rates per injection site of 25 to 30 mL/hour up to 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IgPro20</intervention_name>
    <description>A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
    <arm_group_label>IgPro20 (Manual Push Flow Rate Cohort)</arm_group_label>
    <arm_group_label>IgPro20 (Pump Assisted Flow Rate Cohort)</arm_group_label>
    <arm_group_label>IgPro20 (Pump-Assisted Volume Cohort)</arm_group_label>
    <other_name>Hizentra</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female on stable dose of IgPro20 (Hizentra) therapy.&#xD;
&#xD;
          -  Women of childbearing potential must be using and agree to continue using medically&#xD;
             approved contraception (which must be discussed with the study doctor) and must have a&#xD;
             negative pregnancy test at screening.&#xD;
&#xD;
          -  Subjects with PID, eg, with a diagnosis of common variable immunodeficiency or&#xD;
             X-linked agammaglobulinemia, as defined by the Pan American Group for Immune&#xD;
             Deficiency and the European Society of Immune Deficiencies.&#xD;
&#xD;
          -  With infusion parameters as specified below:&#xD;
&#xD;
        Pump-Assisted Flow Rate Cohort subjects only&#xD;
&#xD;
          -  Experience with pump-assisted infusions of IgPro20 at the tolerated flow rate of 25&#xD;
             mL/h per injection site for at least 1 month prior to Day 1.&#xD;
&#xD;
        Pump-Assisted Volume Cohort subjects only&#xD;
&#xD;
          -  Total weekly IgPro20 dose of ≥ 50 mL (≥ 10 g).&#xD;
&#xD;
          -  Experience with pump-assisted infusions of IgPro20 at tolerated volumes of 25&#xD;
             mL/injection site for at least 1 month prior to Day 1.&#xD;
&#xD;
        Manual Push Flow Rate Cohort subjects only&#xD;
&#xD;
          -  Experience with frequent (2-7 times per week) infusions of IgPro20 at the tolerated&#xD;
             flow rate of approximately 0.5 mL/min (equivalent of 25-30 mL/h) per injection site&#xD;
             for at least 1 month prior to Day 1. The dose (volume) per injection site should not&#xD;
             exceed 25 mL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ongoing serious bacterial infections at the time of screening.&#xD;
&#xD;
          -  Other significant medical conditions that could increase the risk to the subject.&#xD;
&#xD;
          -  Females who are pregnant, breast feeding, or planning a pregnancy during the course&#xD;
             study.&#xD;
&#xD;
          -  Participation in a study with an Investigational Medicinal Product (IMP) other than&#xD;
             IgPro20 within three months prior to enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Physician</last_name>
    <role>Study Director</role>
    <affiliation>CSL Behring</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Center of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Solutions of Arizona</name>
      <address>
        <city>Litchfield Park</city>
        <state>Arizona</state>
        <zip>85340</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern Florida</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Pollens Clinical Research Centers</name>
      <address>
        <city>Albany</city>
        <state>Georgia</state>
        <zip>31707</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Jewish Medical Center</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn Medical Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Research Rochester General Hospital</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levine Children's Hospital</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University School of Medicine</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4A3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <results_first_submitted>December 4, 2019</results_first_submitted>
  <results_first_submitted_qc>December 30, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 13, 2020</results_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Primary Immunodeficiency Diseases</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03033745/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03033745/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>IgPro20 (Pump-Assisted Volume Cohort)</title>
          <description>Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
        </group>
        <group group_id="P2">
          <title>IgPro20 (Pump Assisted Flow Rate Cohort)</title>
          <description>Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
        </group>
        <group group_id="P3">
          <title>IgPro20 (Manual Push Flow Rate Cohort)</title>
          <description>Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IgPro20 (Pump-Assisted Volume Cohort)</title>
          <description>Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
        </group>
        <group group_id="B2">
          <title>IgPro20 (Pump Assisted Flow Rate Cohort)</title>
          <description>Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
        </group>
        <group group_id="B3">
          <title>IgPro20 (Manual Push Flow Rate Cohort)</title>
          <description>Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="16"/>
            <count group_id="B4" value="49"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="49.1" spread="14.18"/>
                    <measurement group_id="B2" value="26.7" spread="24.52"/>
                    <measurement group_id="B3" value="47.9" spread="13.28"/>
                    <measurement group_id="B4" value="40.5" spread="20.97"/>
                  </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="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </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="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Responders</title>
        <description>A responder is a subject within the Pump-Assisted Cohorts that performs at least 3 out of 4 valid infusions at a certain infusion parameter level (weekly volumes per injection site of 25-50 mL; weekly flow rates per injection site of 25-100 mL/hour). Determination of a responder in the Manual Push Cohort is more complex due to the expected variable frequency of infusions per week (ie, 5-17) for different subjects. A responder within the Manual Push Cohort is a subject that performs a minimum number of valid infusions during 4 weeks corresponding to a certain flow rate level ([ie, 2-7 times per week], flow rates per injection site of 30-120 mL/hour). Valid infusions do not need to be consecutive, but each subject needs to adhere to the same schedule (number of infusions per week) throughout the study. An infusion parameter will be considered successful if at least one third (≥ 33%) of the subjects in the corresponding cohort are responders at that infusion parameter level.</description>
        <time_frame>At the end of 4 weeks for each planned infusion parameter</time_frame>
        <population>The Safety Analysis Set (SAS) comprised all subjects in the Full Analysis Set who received ≥ 1 dose or a partial dose of IgPro20 in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>IgPro20 (Pump-Assisted Volume Cohort)</title>
            <description>Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
          <group group_id="O2">
            <title>IgPro20 (Pump Assisted Flow Rate Cohort)</title>
            <description>Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
          <group group_id="O3">
            <title>IgPro20 (Manual Push Flow Rate Cohort)</title>
            <description>Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders</title>
          <description>A responder is a subject within the Pump-Assisted Cohorts that performs at least 3 out of 4 valid infusions at a certain infusion parameter level (weekly volumes per injection site of 25-50 mL; weekly flow rates per injection site of 25-100 mL/hour). Determination of a responder in the Manual Push Cohort is more complex due to the expected variable frequency of infusions per week (ie, 5-17) for different subjects. A responder within the Manual Push Cohort is a subject that performs a minimum number of valid infusions during 4 weeks corresponding to a certain flow rate level ([ie, 2-7 times per week], flow rates per injection site of 30-120 mL/hour). Valid infusions do not need to be consecutive, but each subject needs to adhere to the same schedule (number of infusions per week) throughout the study. An infusion parameter will be considered successful if at least one third (≥ 33%) of the subjects in the corresponding cohort are responders at that infusion parameter level.</description>
          <population>The Safety Analysis Set (SAS) comprised all subjects in the Full Analysis Set who received ≥ 1 dose or a partial dose of IgPro20 in the study.</population>
          <units>percentage of responders</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>25 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="77.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="77.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="61.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="87.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion</title>
        <description>Adverse event rate per infusion = number of adverse events/total number of infusions prior to subject's start date of non-response. Only events are included which start prior to subject's start date of non-response.</description>
        <time_frame>At the end of 4 weeks for each planned infusion parameter</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>IgPro20 (Pump-Assisted Volume Cohort)</title>
            <description>Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
          <group group_id="O2">
            <title>IgPro20 (Pump Assisted Flow Rate Cohort)</title>
            <description>Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
          <group group_id="O3">
            <title>IgPro20 (Manual Push Flow Rate Cohort)</title>
            <description>Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion</title>
          <description>Adverse event rate per infusion = number of adverse events/total number of infusions prior to subject's start date of non-response. Only events are included which start prior to subject's start date of non-response.</description>
          <population>SAS</population>
          <units>Number of TEAEs/infusion</units>
          <param>Number</param>
          <units_analyzed>Infusions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Infusions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="222"/>
                <count group_id="O3" value="626"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>25 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.023"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.329"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.085"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0.064"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0.111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="198"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0.081"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Local TEAEs Per Infusion</title>
        <description>Local adverse event rate per infusion = number of local adverse events/total number of infusions prior to subject's start date of non-response. Local Adverse Events: comprises all events reported within the MedDRA high level terms &quot;administration site reactions NEC (Not Elsewhere Classified)&quot;, &quot;infusion site reactions&quot;, and &quot;injection site reactions&quot;. Only events are included which start prior to subject's start date of non-response.</description>
        <time_frame>At the end of 4 weeks for each planned infusion parameter</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>IgPro20 (Pump-Assisted Volume Cohort)</title>
            <description>Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
          <group group_id="O2">
            <title>IgPro20 (Pump Assisted Flow Rate Cohort)</title>
            <description>Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
          <group group_id="O3">
            <title>IgPro20 (Manual Push Flow Rate Cohort)</title>
            <description>Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Local TEAEs Per Infusion</title>
          <description>Local adverse event rate per infusion = number of local adverse events/total number of infusions prior to subject's start date of non-response. Local Adverse Events: comprises all events reported within the MedDRA high level terms &quot;administration site reactions NEC (Not Elsewhere Classified)&quot;, &quot;infusion site reactions&quot;, and &quot;injection site reactions&quot;. Only events are included which start prior to subject's start date of non-response.</description>
          <population>SAS</population>
          <units>Number of local TEAEs/infusion</units>
          <param>Number</param>
          <units_analyzed>Infusions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Infusions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="222"/>
                <count group_id="O3" value="626"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>25 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.063"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.040"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.021"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0.027"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0.082"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="198"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0.025"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Onset of Local TEAEs</title>
        <description>Local Adverse Events: comprises all events reported within the MedDRA high level terms &quot;administration site reactions NEC&quot;, &quot;infusion site reactions&quot;, and &quot;injection site reactions&quot;. Only events are included which start prior to subject's start date of non-response.</description>
        <time_frame>At the end of 4 weeks for each planned infusion parameter</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>IgPro20 (Pump-Assisted Volume Cohort)</title>
            <description>Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
          <group group_id="O2">
            <title>IgPro20 (Pump Assisted Flow Rate Cohort)</title>
            <description>Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
          <group group_id="O3">
            <title>IgPro20 (Manual Push Flow Rate Cohort)</title>
            <description>Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Onset of Local TEAEs</title>
          <description>Local Adverse Events: comprises all events reported within the MedDRA high level terms &quot;administration site reactions NEC&quot;, &quot;infusion site reactions&quot;, and &quot;injection site reactions&quot;. Only events are included which start prior to subject's start date of non-response.</description>
          <population>SAS</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Local TEAEs</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Local TEAEs</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>25 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="2.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>25 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.7" spread="2.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0" spread="NA">Not estimable because events = 1</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0.2" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0.3" spread="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0.2" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intensity of Local TEAEs</title>
        <description>Mild = A type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate = A type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the subject. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response.</description>
        <time_frame>At the end of 4 weeks for each planned infusion parameter</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>IgPro20 (Pump-Assisted Volume Cohort)</title>
            <description>Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
          <group group_id="O2">
            <title>IgPro20 (Pump Assisted Flow Rate Cohort)</title>
            <description>Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
          <group group_id="O3">
            <title>IgPro20 (Manual Push Flow Rate Cohort)</title>
            <description>Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
        </group_list>
        <measure>
          <title>Intensity of Local TEAEs</title>
          <description>Mild = A type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate = A type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the subject. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response.</description>
          <population>SAS</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="15"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>25 ml (mild)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25 ml (moderate)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25 ml (severe)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40 ml (mild)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40 ml (moderate)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40 ml (severe)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml (mild)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml (moderate)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml (severe)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25 ml/h (mild)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25 ml/h (moderate)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25 ml/h (severe)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml/h (mild)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml/h (moderate)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml/h (severe)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75 ml/h (mild)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75 ml/h (moderate)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75 ml/h (severe)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100 ml/h (mild)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100 ml/h (moderate)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100 ml/h (severe)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 ml/h (mild)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 ml/h (moderate)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 ml/h (severe)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 ml/h (mild)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 ml/h (moderate)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 ml/h (severe)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 ml/h (mild)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 ml/h (moderate)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 ml/h (severe)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Local TEAEs</title>
        <description>Local Adverse Events: comprises all events reported within the MedDRA high level terms &quot;administration site reactions NEC&quot;, &quot;infusion site reactions&quot;, and &quot;injection site reactions&quot;.</description>
        <time_frame>At the end of 4 weeks for each planned infusion parameter</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>IgPro20 (Pump-Assisted Volume Cohort)</title>
            <description>Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
          <group group_id="O2">
            <title>IgPro20 (Pump Assisted Flow Rate Cohort)</title>
            <description>Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
          <group group_id="O3">
            <title>IgPro20 (Manual Push Flow Rate Cohort)</title>
            <description>Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Local TEAEs</title>
          <description>Local Adverse Events: comprises all events reported within the MedDRA high level terms &quot;administration site reactions NEC&quot;, &quot;infusion site reactions&quot;, and &quot;injection site reactions&quot;.</description>
          <population>SAS</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Local TEAEs</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Local TEAEs</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>25 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="2.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>25 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.2" spread="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.6" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.0" spread="NA">Not estimable because events = 1</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="2.2" spread="2.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="5.6" spread="12.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Local TEAEs</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="3.0" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tolerability of Infusions</title>
        <description>Tolerability = number of infusions without severe local adverse events / total number of infusions. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response.</description>
        <time_frame>At the end of 4 weeks for each planned infusion parameter</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>IgPro20 (Pump-Assisted Volume Cohort)</title>
            <description>Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
          <group group_id="O2">
            <title>IgPro20 (Pump Assisted Flow Rate Cohort)</title>
            <description>Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
          <group group_id="O3">
            <title>IgPro20 (Manual Push Flow Rate Cohort)</title>
            <description>Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.&#xD;
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.</description>
          </group>
        </group_list>
        <measure>
          <title>Tolerability of Infusions</title>
          <description>Tolerability = number of infusions without severe local adverse events / total number of infusions. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response.</description>
          <population>SAS</population>
          <units>Ratio</units>
          <param>Number</param>
          <units_analyzed>Infusions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Infusions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="222"/>
                <count group_id="O3" value="626"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>25 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 ml/h</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Infusions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="198"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 17 weeks per participant</time_frame>
      <group_list>
        <group group_id="E1">
          <title>IgPro20 (Pump-assisted Volume) 25 mL</title>
          <description>Volumes per injection site of 25 mL administered subcutaneously.</description>
        </group>
        <group group_id="E2">
          <title>IgPro20 (Pump-assisted Volume) 40 mL</title>
          <description>Volumes per injection site of 40 mL administered subcutaneously.</description>
        </group>
        <group group_id="E3">
          <title>IgPro20 (Pump-assisted Volume) 50 mL</title>
          <description>Volumes per injection site of 50 mL administered subcutaneously.</description>
        </group>
        <group group_id="E4">
          <title>IgPro20 (Pump-assisted Flow Rate) 25 mL/h</title>
          <description>Flow rates per injection site of 25 mL/hour administered subcutaneously.</description>
        </group>
        <group group_id="E5">
          <title>IgPro20 (Pump-assisted Flow Rate) 50 mL/h</title>
          <description>Flow rates per injection site of 50 mL/hour administered subcutaneously.</description>
        </group>
        <group group_id="E6">
          <title>IgPro20 (Pump-assisted Flow Rate) 75 mL/h</title>
          <description>Flow rates per injection site of 75 mL/hour administered subcutaneously.</description>
        </group>
        <group group_id="E7">
          <title>IgPro20 (Pump-assisted Flow Rate) 100 mL/h</title>
          <description>Flow rates per injection site of 100 mL/hour administered subcutaneously.</description>
        </group>
        <group group_id="E8">
          <title>IgPro20 (Manual Push Flow Rate) 30 mL/h</title>
          <description>Flow rates per injection site of approximately 30 mL/hour administered subcutaneously.</description>
        </group>
        <group group_id="E9">
          <title>IgPro20 (Manual Push Flow Rate) 60 mL/h</title>
          <description>Flow rates per injection site of approximately 60 mL/hour administered subcutaneously.</description>
        </group>
        <group group_id="E10">
          <title>IgPro20 (Manual Push Flow Rate) 120 mL/h</title>
          <description>Flow rates per injection site of approximately 120 mL/hour administered subcutaneously.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>suicide attempt</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E9" subjects_affected="8" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E9" events="3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="8" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="7" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E5" events="5" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="4" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E9" events="4" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Injection site extravasation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Injection site hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Injection site mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E10" events="3" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Injection site discoloration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Gait inability</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to arthropod bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Tinea infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Trigeminal neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertonic bladder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </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>CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Trial Registration Coordinator</name_or_title>
      <organization>CSL Behring</organization>
      <phone>610 878-4000</phone>
      <email>clinicaltrials@cslbehring.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/NCT03033745
org study id: IgPro20_4004
secondary id: 2016-003799-33
nct id: NCT03033745
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This multicenter, open-label, parallel-arm, non-randomized study is designed to evaluate
      safety and tolerability of higher infusion parameters of IgPro20 in subjects with primary
      immunodeficiency (PID). A total of 45 subjects (including at least 14 [30%] pediatric
      subjects ≤ 17 years of age and at least 9 [20%] obese subjects with body mass index [BMI] of
      ≥30 kg/m2) with confirmed PID will be evaluated in the study. The study will include three
      cohorts of 15 subjects each as follows: i) Pump-Assisted Volume Cohort (weekly infusions),
      volume per injection site of 25 mL up to 50 mL, ii) Pump Assisted Flow Rate Cohort (weekly
      infusions), flow rate per injection site of 25 mL/hour up to 100 mL/hour, iii) Manual Push
      Flow Rate Cohort (2 to 7 infusions per week), flow rate per injection site of 25 to 30
      mL/hour up to 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute). Each
      cohort will test 3 infusion parameter levels (4 for the pump-assisted flow rate cohort),
      repeated at least 4 times over a duration of 12 weeks (16 weeks for the flow rate cohort).
      After 4 infusion weeks at each level, qualifying subjects (responders) will switch to the
      next infusion parameter level (eg, from 25 to 50 mL/h). During the study, the weekly dose
      will remain unchanged (as prescribed by treating physician, usually within 100-200 mg/kg per
      week range); only the respective infusion parameter under evaluation will change.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Responders
time frame: At the end of 4 weeks for each planned infusion parameter
description: A responder is a subject within the Pump-Assisted Cohorts that performs at least 3 out of 4 valid infusions at a certain infusion parameter level (weekly volumes per injection site of 25-50 mL; weekly flow rates per injection site of 25-100 mL/hour). Determination of a responder in the Manual Push Cohort is more complex due to the expected variable frequency of infusions per week (ie, 5-17) for different subjects. A responder within the Manual Push Cohort is a subject that performs a minimum number of valid infusions during 4 weeks corresponding to a certain flow rate level ([ie, 2-7 times per week], flow rates per injection site of 30-120 mL/hour). Valid infusions do not need to be consecutive, but each subject needs to adhere to the same schedule (number of infusions per week) throughout the study. An infusion parameter will be considered successful if at least one third (≥ 33%) of the subjects in the corresponding cohort are responders at that infusion parameter level.
measure: Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion
time frame: At the end of 4 weeks for each planned infusion parameter
description: Adverse event rate per infusion = number of adverse events/total number of infusions prior to subject's start date of non-response. Only events are included which start prior to subject's start date of non-response.
measure: Rate of Local TEAEs Per Infusion
time frame: At the end of 4 weeks for each planned infusion parameter
description: Local adverse event rate per infusion = number of local adverse events/total number of infusions prior to subject's start date of non-response. Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC (Not Elsewhere Classified)", "infusion site reactions", and "injection site reactions". Only events are included which start prior to subject's start date of non-response.
measure: Time to Onset of Local TEAEs
time frame: At the end of 4 weeks for each planned infusion parameter
description: Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC", "infusion site reactions", and "injection site reactions". Only events are included which start prior to subject's start date of non-response.
measure: Intensity of Local TEAEs
time frame: At the end of 4 weeks for each planned infusion parameter
description: Mild = A type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate = A type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the subject. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response.
measure: Duration of Local TEAEs
time frame: At the end of 4 weeks for each planned infusion parameter
description: Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC", "infusion site reactions", and "injection site reactions".
measure: Tolerability of Infusions
time frame: At the end of 4 weeks for each planned infusion parameter
description: Tolerability = number of infusions without severe local adverse events / total number of infusions. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response.
arm group label: IgPro20 (Pump-Assisted Volume Cohort)
arm group type: Experimental
description: Weekly volumes per injection site of 25 mL up to 50 mL administered subcutaneously.
arm group label: IgPro20 (Pump Assisted Flow Rate Cohort)
arm group type: Experimental
description: Weekly flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.
arm group label: IgPro20 (Manual Push Flow Rate Cohort)
arm group type: Experimental
description: Frequent (ie, 2 to 7 times per week) flow rates per injection site of 25 to 30 mL/hour up to 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.
intervention type: Drug
intervention name: IgPro20
description: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
arm group label: IgPro20 (Manual Push Flow Rate Cohort)
arm group label: IgPro20 (Pump Assisted Flow Rate Cohort)
arm group label: IgPro20 (Pump-Assisted Volume Cohort)
other name: Hizentra
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
last name: Study Physician
role: Study Director
affiliation: CSL Behring
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Primary Immunodeficiency Diseases
mesh term: Immunologic Deficiency Syndromes
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 