<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/NCT02994927</url>
  </required_header>
  <id_info>
    <org_study_id>CL010_168</org_study_id>
    <secondary_id>ADVOCATE</secondary_id>
    <nct_id>NCT02994927</nct_id>
  </id_info>
  <brief_title>A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis</brief_title>
  <acronym>ADVOCATE</acronym>
  <official_title>A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ChemoCentryx</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ChemoCentryx</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>
      The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain&#xD;
      remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated&#xD;
      vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or&#xD;
      in combination with rituximab.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Complement 5a and its receptor C5aR (CD88) are involved in the pathogenesis of&#xD;
      anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.&#xD;
&#xD;
      This is a randomized, double-blind, active-controlled Phase 3 study to evaluate the safety&#xD;
      and efficacy of the orally-administered, selective C5aR inhibitor CCX168 (avacopan) in&#xD;
      inducing and sustaining remission in patients with anti-neutrophil cytoplasmic antibody&#xD;
      (ANCA)-associated vasculitis (AAV) treated concomitantly with Rituximab or&#xD;
      Cyclophosphamide/Azathioprine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 7, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>This study was double-blind, double-dummy, i.e., placebo capsules were identical in appearance to the avacopan capsules, and prednisone capsules also had matching placebo capsules. To maintain the blind, multiple measures were taken (i.e., randomization code was not accessible to study personnel who had contact with study centers or who were involved in data management and analysis for the duration of the study).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects Achieving Disease Remission at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>Disease remission at Week 26 was defined as:&#xD;
Achieving a BVAS of 0 as determined by the Adjudication Committee;&#xD;
No administration of glucocorticoids given for ANCA-associated vasculitis within 4 weeks prior to Week 26;&#xD;
No BVAS &gt;0 during the 4 weeks prior to Week 26 (if collected for an unscheduled assessment).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects Achieving Sustained Disease Remission at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>Sustained remission at Week 52 was defined as:&#xD;
Disease remission at Week 26 as defined above;&#xD;
Disease remission at Week 52 defined as a BVAS of 0 at Week 52 as determined by the Adjudication Committee and no administration of glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 52;&#xD;
No disease relapse between Week 26 and Week 52 as determined by the Adjudication Committee.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs</measure>
    <time_frame>From day 1 throughout the study period (day 421/week 60)</time_frame>
    <description>AEs=Adverse events&#xD;
SAEs=Serious adverse events&#xD;
TEAE=Treatment-emergent adverse event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI</measure>
    <time_frame>Baseline, Week 13 and 26</time_frame>
    <description>GTI-CWS=Glucocorticoid Toxicity Index Cumulative Worsening Score;&#xD;
GTI-AIS=Glucocorticoid Toxicity Index Aggregate Improvement Score;&#xD;
The Glucocorticoid Toxicity Index (GTI) was developed to score glucocorticoid toxicity. The GTI includes: the Cumulative Worsening Score (CWS) that captures cumulative toxicity, both permanent and transient, over the course of time (serves as a cumulative record of toxicity); and the Aggregate Improvement Score that captures both improvement and worsening of toxicity over time (serves as a record of both improving and worsening toxicity). Both scores range from 0 (best health) to 100 (worst health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC</measure>
    <time_frame>Week 4</time_frame>
    <description>AC=Adjudication Committee; BVAS=Birmingham Vasculitis Activity Score;&#xD;
The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Over 52 Weeks in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36v2 and EQ-5D-5L VAS and Index</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
    <description>SF-36v2: Measure of health- related quality of life (Medical Outcomes Survey Short Form-36 version 2)&#xD;
EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels&#xD;
The SF-36v2 component scores and the EQ-5D-5L VAS score range from 0 (worst health) to 100 (best health). The EQ-5D-5L Index Score ranges from 0 (worst health) to 1 (best health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study</measure>
    <time_frame>Week 52</time_frame>
    <description>The median time to relapse was not estimable because of small number of relapsed subjects.&#xD;
A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:&#xD;
having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or&#xD;
having achieved BVAS=0 at any time during the treatment period&#xD;
ANCA=anti-neutrophil cytoplasmic autoantibody; BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period</measure>
    <time_frame>Week 52</time_frame>
    <description>The median time to relapse was not estimable because of small number of relapsed subjects.&#xD;
A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:&#xD;
having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or&#xD;
having achieved BVAS=0 at any time during the treatment period&#xD;
The Birmingham Vasculitis Activity Score (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
    <description>Change from baseline in kidney function, as measured by eGFR (based on the MDRD equation), was measured in subjects with renal disease based on the BVAS renal component.&#xD;
eGFR=estimated glomerular filtration rate&#xD;
BVAS=Birmingham Vasculitis Activity Score&#xD;
MDRD=Modification of Diet in Renal Disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks</measure>
    <time_frame>Baseline, Week 4, 26 and 52</time_frame>
    <description>BVAS=Birmingham Vasculitis Activity Score&#xD;
UACR=Urinary albumin:creatinine ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
    <description>BVAS=Birmingham Vasculitis Activity Score&#xD;
MCP-1=monocyte chemoattractant protein-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
    <description>VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5)</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5)</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5)</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5)</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5)</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2)</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2)</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vital Signs (1/5)</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vital Signs (2/5)</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vital Signs (3/5)</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vital Signs (4/5)</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vital Signs (5/5)</measure>
    <time_frame>Baseline, Week 26 and 52</time_frame>
    <description>BMI=Body Mass Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Clinically Significant ECG Changes From Baseline</measure>
    <time_frame>From day 1 throughout the study period (day 421/week 60)</time_frame>
    <description>Clinical significance was assessed by the individual reading of the ECGs&#xD;
ECG=Electrocardiogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Where a Relationship Between Avacopan/Placebo, Glucocorticoid Use, Cyclophosphamide, Rituximab, and Azathioprine or Mycophenolate Use to an AE Was Determined by the Investigator</measure>
    <time_frame>From day 1 throughout the study period (day 421/week 60)</time_frame>
    <description>AE=Adverse Event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity</measure>
    <time_frame>From day 1 throughout the study period (day 421/week 60)</time_frame>
    <description>WBC=White Blood Cell&#xD;
TEAE=Treatment-Emergent Adverse Event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study</measure>
    <time_frame>From day 1 throughout the study period (day 421/week 60)</time_frame>
    <description>BVAS=Birmingham Vasculitis Activity Score;&#xD;
A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:&#xD;
having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or&#xD;
having achieved BVAS=0 at any time during the treatment period&#xD;
The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">331</enrollment>
  <condition>ANCA-Associated Vasculitis</condition>
  <arm_group>
    <arm_group_label>Prednisone group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Avacopan group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Avacopan</intervention_name>
    <description>Avacopan 30 mg twice daily orally for 52 weeks (364 days):&#xD;
- Three 10 mg avacopan capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose.&#xD;
Oral prednisone-matching placebo tapering regimen over 20 weeks (140 days):&#xD;
Prednisone-matching placebo capsules equivalent to 60 mg per day if the subject's body weight was ≥55 kg, or 45 mg per day if the subject's body weight was &lt;55 kg, starting on Day 1 with tapering according to a protocol-specified schedule.&#xD;
Adolescents who weighed ≤37 kg started at a prednisone-matching placebo dose of 30 mg per day.</description>
    <arm_group_label>Avacopan group</arm_group_label>
    <other_name>CCX168</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Avacopan-matching placebo twice daily orally for 52 weeks (364 days):&#xD;
- Three avacopan-matching placebo capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose.&#xD;
Oral prednisone tapering regimen over 20 weeks (140 days):&#xD;
Prednisone 60 mg per day if the subject's body weight was ≥55 kg, or 45 mg per day if the subject's body weight was &lt;55 kg, starting on Day 1 with tapering according to the protocol-specified schedule.&#xD;
Adolescents who weighed ≤37 kg started at a prednisone dose of 30 mg per day.</description>
    <arm_group_label>Prednisone group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Orally or intravenously administered</description>
    <arm_group_label>Avacopan group</arm_group_label>
    <arm_group_label>Prednisone group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Intravenously administered</description>
    <arm_group_label>Avacopan group</arm_group_label>
    <arm_group_label>Prednisone group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azathioprine</intervention_name>
    <description>Orally administered</description>
    <arm_group_label>Avacopan group</arm_group_label>
    <arm_group_label>Prednisone group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of granulomatosis with polyangiitis (Wegener's) or microscopic&#xD;
             polyangiitis&#xD;
&#xD;
          -  Male and female subjects, aged at least 18 years, with newly-diagnosed or relapsed&#xD;
             associated vasculitis (AAV) where treatment with cyclophosphamide or rituximab is&#xD;
             needed; where approved by Regulatory Agencies, adolescents (12-17 year old) may be&#xD;
             enrolled&#xD;
&#xD;
          -  Use of adequate contraception&#xD;
&#xD;
          -  Positive test for anti-proteinase 3 (PR3) or anti-myeloperoxidase (MPO)&#xD;
&#xD;
          -  At least 1 major item, or at least 3 non-major items, or at least the 2 renal items of&#xD;
             proteinuria and hematuria on Birmingham Vasculitis Activity Score (BVAS)&#xD;
&#xD;
          -  Estimated glomerular filtration rate ≥15 mL/minute/1.73 m^2 at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding&#xD;
&#xD;
          -  Alveolar hemorrhage requiring pulmonary ventilation support at screening&#xD;
&#xD;
          -  Any other known multi-system autoimmune disease&#xD;
&#xD;
          -  Required dialysis or plasma exchange within 12 weeks prior to screening&#xD;
&#xD;
          -  Have a kidney transplant&#xD;
&#xD;
          -  Received cyclophosphamide within 12 weeks prior to screening; if on azathioprine,&#xD;
             mycophenolate mofetil or methotrexate at the time of screening, these drugs must be&#xD;
             withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1&#xD;
&#xD;
          -  Received intravenous glucocorticoids, &gt;3000 mg methylprednisolone equivalent, within 4&#xD;
             weeks prior to screening&#xD;
&#xD;
          -  Have been taking an oral daily dose of a glucocorticoid of more than 10 mg&#xD;
             prednisone-equivalent for more than 6 weeks continuously prior to screening&#xD;
&#xD;
          -  Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks&#xD;
             provided B cell reconstitution has occurred (i.e., CD19 count &gt; 0.01x10^9/L); received&#xD;
             anti-tumor necrosis factor (TNF) treatment, abatacept, alemtuzumab, intravenous&#xD;
             immunoglobulin (IVIg), belimumab, tocilizumab, or eculizumab within 12 weeks prior to&#xD;
             screening&#xD;
&#xD;
          -  For patients scheduled to receive cyclophosphamide treatment, urinary outflow&#xD;
             obstruction, active infection (especially varicella zoster infection), or platelet&#xD;
             count &lt;50,000/μL before start of dosing&#xD;
&#xD;
          -  Participated previously in a CCX168 study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71101</zip>
        <country>United States</country>
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  <location>
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      <address>
        <city>Baltimore</city>
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        <zip>21224</zip>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Boston</city>
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  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
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        <zip>02118</zip>
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  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
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        <city>Ann Arbor</city>
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  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
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        <city>Minneapolis</city>
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  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
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        <city>Rochester</city>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
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        <city>Saint Louis</city>
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        <country>United States</country>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Great Neck</city>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Mineola</city>
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        <zip>11501</zip>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>New York</city>
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  <location>
    <facility>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
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        <city>Chapel Hill</city>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
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        <city>Greenville</city>
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        <zip>27834</zip>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
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        <city>Cleveland</city>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
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        <city>Columbus</city>
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        <zip>43210</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
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        <city>Philadelphia</city>
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        <zip>19104</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Providence</city>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
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        <city>Charleston</city>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
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        <city>Dallas</city>
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        <country>United States</country>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Houston</city>
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        <country>United States</country>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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      <address>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Monza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Parma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Reggio Emilia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Udine</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Aichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Akita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Ishikawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Kagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Kobe</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Miyazaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Nagoya</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Shimane</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Toyama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Yokohama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Leiden</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Christchurch</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Dunedin</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Grafton</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Hamilton</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Takapuna</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Nordbyhagen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Tromsø</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Badalona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Burela</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Lleida</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>San Sebastián</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Linköping</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Lund</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Örebro</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Basel</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Fribourg</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Lausanne</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>St. Gallen</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Zürich</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Aberdeen</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Basildon</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Canterbury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Carshalton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Dorchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Dudley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Exeter</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Inverness</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Kirkcaldy</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Leicester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Newcastle</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Reading</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Salford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Westcliff-on-Sea</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Norway</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <results_first_submitted>May 19, 2022</results_first_submitted>
  <results_first_submitted_qc>August 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 9, 2022</results_first_posted>
  <last_update_submitted>August 24, 2023</last_update_submitted>
  <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ANCA-associated vasculitis</keyword>
  <keyword>complement</keyword>
  <keyword>vasculitis</keyword>
  <keyword>C5aR</keyword>
  <keyword>avacopan</keyword>
  <keyword>CCX168</keyword>
  <keyword>MPA</keyword>
  <keyword>GPA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vasculitis</mesh_term>
    <mesh_term>Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Azathioprine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.</ipd_access_criteria>
    <ipd_url>http://www.amgen.com/datasharing</ipd_url>
  </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>January 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT02994927/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>October 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT02994927/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 143 study centers randomized at least 1 subject. The target enrollment was 300 subjects.</recruitment_details>
      <pre_assignment_details>Screening details:&#xD;
Of 386 subjects screened, 331 were enrolled in the study and randomized to treatment. Reasons for subjects failing screening included not meeting inclusion/exclusion criteria, withdrawal by subject, adverse event (AE) and other.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Prednisone Group</title>
          <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone</description>
        </group>
        <group group_id="P2">
          <title>Avacopan Group</title>
          <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="165"/>
                <participants group_id="P2" count="166"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="150"/>
                <participants group_id="P2" count="151"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by parent/guardian</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not meet eligibility criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>In the Prednisone group, one subject was randomized but withdrawn for not meeting disease criteria prior to dosing.</population>
      <group_list>
        <group group_id="B1">
          <title>Prednisone Group</title>
          <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone</description>
        </group>
        <group group_id="B2">
          <title>Avacopan Group</title>
          <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="164"/>
            <count group_id="B2" value="166"/>
            <count group_id="B3" value="330"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Adolescents (12-17 years)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adults (18-50 years)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adults (51-64 years)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adults (65-75 years)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adults (&gt;75 years)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="46"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="144"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                    <measurement group_id="B2" value="151"/>
                    <measurement group_id="B3" value="308"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="10"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="32"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                    <measurement group_id="B2" value="138"/>
                    <measurement group_id="B3" value="278"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </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>Australia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Denmark</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Zealand</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ireland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sweden</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Switzerland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Geographic Region</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>North America</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Europe and Rest of World excluding Japan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="129"/>
                    <measurement group_id="B2" value="121"/>
                    <measurement group_id="B3" value="250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ANCA-associated vasculitis Status</title>
          <description>ANCA=anti-neutrophil cytoplasmic autoantibody</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Newly diagnosed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relapsed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ANCA Positivity</title>
          <description>ANCA=anti-neutrophil cytoplasmic autoantibody</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Proteinase 3 (PR3)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myeloperoxidase (MPO)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Standard of Care Treatment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Rituximab</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intravenous (IV) Cyclophosphamide</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral Cyclophosphamide</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of ANCA-associated vasculitis</title>
          <description>ANCA=anti-neutrophil cytoplasmic autoantibody</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Granulomatosis with polyangiitis (GPA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Microscopic polyangiitis (MPA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BVAS Entry Criteria</title>
          <description>BVAS=Birmingham Vasculitis Activity Score;&#xD;
The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).&#xD;
* Subjects can appear in more than one category</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>One or more major item</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Three or more minor items</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="142"/>
                    <measurement group_id="B2" value="146"/>
                    <measurement group_id="B3" value="288"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Two renal items of proteinuria and hematuria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BVAS Components</title>
          <description>BVAS=Birmingham Vasculitis Activity Score&#xD;
* Subjects can appear in more than one category</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>General</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cutaneous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mucous Membranes/Eyes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear Nose and Throat</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chest</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiovascular</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal + Other (RBC Casts and/or Glomerulonephritis)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="134"/>
                    <measurement group_id="B2" value="134"/>
                    <measurement group_id="B3" value="268"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nervous System</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age at screening</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.5" spread="14.50"/>
                    <measurement group_id="B2" value="61.2" spread="14.56"/>
                    <measurement group_id="B3" value="60.9" spread="14.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age at diagnosis of ANCA-associated Vasculitis</title>
          <description>ANCA=anti-neutrophil cytoplasmic autoantibody</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.4" spread="15.19"/>
                    <measurement group_id="B2" value="59.8" spread="15.60"/>
                    <measurement group_id="B3" value="59.6" spread="15.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of ANCA-Associated Vasculitis</title>
          <description>ANCA=anti-neutrophil cytoplasmic autoantibody</description>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.13" spread="40.473"/>
                    <measurement group_id="B2" value="22.93" spread="52.464"/>
                    <measurement group_id="B3" value="21.54" spread="46.840"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Weight</title>
          <units>kilogram(s)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77.71" spread="19.335"/>
                    <measurement group_id="B2" value="76.43" spread="20.254"/>
                    <measurement group_id="B3" value="77.07" spread="19.783"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <description>BMI=Body Mass Index</description>
          <population>Two subjects did not have a baseline BMI provided (one in each treatment group)</population>
          <units>kilogram(s)/square meter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                    <count group_id="B2" value="165"/>
                    <count group_id="B3" value="328"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.78" spread="5.212"/>
                    <measurement group_id="B2" value="26.72" spread="5.997"/>
                    <measurement group_id="B3" value="26.75" spread="5.612"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BVAS Score</title>
          <description>BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="164"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="330"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.2" spread="5.69"/>
                    <measurement group_id="B2" value="16.3" spread="5.87"/>
                    <measurement group_id="B3" value="16.2" spread="5.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>VDI Score</title>
          <description>VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health).</description>
          <population>Two subjects did not have a baseline VDI Score (one in each treatment group)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                    <count group_id="B2" value="165"/>
                    <count group_id="B3" value="328"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.7" spread="1.39"/>
                    <measurement group_id="B2" value="0.7" spread="1.54"/>
                    <measurement group_id="B3" value="0.7" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Achieving Disease Remission at Week 26</title>
        <description>Disease remission at Week 26 was defined as:&#xD;
Achieving a BVAS of 0 as determined by the Adjudication Committee;&#xD;
No administration of glucocorticoids given for ANCA-associated vasculitis within 4 weeks prior to Week 26;&#xD;
No BVAS &gt;0 during the 4 weeks prior to Week 26 (if collected for an unscheduled assessment).</description>
        <time_frame>Week 26</time_frame>
        <population>Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Achieving Disease Remission at Week 26</title>
          <description>Disease remission at Week 26 was defined as:&#xD;
Achieving a BVAS of 0 as determined by the Adjudication Committee;&#xD;
No administration of glucocorticoids given for ANCA-associated vasculitis within 4 weeks prior to Week 26;&#xD;
No BVAS &gt;0 during the 4 weeks prior to Week 26 (if collected for an unscheduled assessment).</description>
          <population>Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.1" lower_limit="62.5" upper_limit="77.0"/>
                    <measurement group_id="O2" value="72.3" lower_limit="64.8" upper_limit="78.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The proportion of subjects achieving disease remission at Week 26 and the two-sided 95% confidence intervals (CIs) for the difference in proportions was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.</non_inferiority_desc>
            <p_value>&lt; 0.0001</p_value>
            <method>Summary score test</method>
            <param_type>Common difference in remission rates</param_type>
            <param_value>3.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.0</ci_lower_limit>
            <ci_upper_limit>12.8</ci_upper_limit>
            <estimate_desc>Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The proportion of subjects achieving disease remission at Week 26 and the two-sided 95% confidence intervals (CIs) for the difference in proportions was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.</non_inferiority_desc>
            <p_value>= 0.2387</p_value>
            <method>Summary score test</method>
            <param_type>Common difference in remission rates</param_type>
            <param_value>3.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.0</ci_lower_limit>
            <ci_upper_limit>12.8</ci_upper_limit>
            <estimate_desc>Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Achieving Sustained Disease Remission at Week 52</title>
        <description>Sustained remission at Week 52 was defined as:&#xD;
Disease remission at Week 26 as defined above;&#xD;
Disease remission at Week 52 defined as a BVAS of 0 at Week 52 as determined by the Adjudication Committee and no administration of glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 52;&#xD;
No disease relapse between Week 26 and Week 52 as determined by the Adjudication Committee.</description>
        <time_frame>Week 52</time_frame>
        <population>Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Achieving Sustained Disease Remission at Week 52</title>
          <description>Sustained remission at Week 52 was defined as:&#xD;
Disease remission at Week 26 as defined above;&#xD;
Disease remission at Week 52 defined as a BVAS of 0 at Week 52 as determined by the Adjudication Committee and no administration of glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 52;&#xD;
No disease relapse between Week 26 and Week 52 as determined by the Adjudication Committee.</description>
          <population>Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.9" lower_limit="46.9" upper_limit="62.6"/>
                    <measurement group_id="O2" value="65.7" lower_limit="57.9" upper_limit="72.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The proportion of subjects achieving sustained disease remission at Week 52, and the two-sided 95% confidence intervals (CIs) for the difference in proportions (avacopan minus prednisone) was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.</non_inferiority_desc>
            <p_value>&lt; 0.0001</p_value>
            <method>Summary score test</method>
            <param_type>Common difference in remission rates</param_type>
            <param_value>12.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.6</ci_lower_limit>
            <ci_upper_limit>22.3</ci_upper_limit>
            <estimate_desc>Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The proportion of subjects achieving sustained disease remission at Week 52, and the two-sided 95% confidence intervals (CIs) for the difference in proportions (avacopan minus prednisone) was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.</non_inferiority_desc>
            <p_value>= 0.0066</p_value>
            <method>Summary score test</method>
            <param_type>Common difference in remission rates</param_type>
            <param_value>12.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.6</ci_lower_limit>
            <ci_upper_limit>22.3</ci_upper_limit>
            <estimate_desc>Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs</title>
        <description>AEs=Adverse events&#xD;
SAEs=Serious adverse events&#xD;
TEAE=Treatment-emergent adverse event</description>
        <time_frame>From day 1 throughout the study period (day 421/week 60)</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs</title>
          <description>AEs=Adverse events&#xD;
SAEs=Serious adverse events&#xD;
TEAE=Treatment-emergent adverse event</description>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.</population>
          <units>Number</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of subjects with at least one TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161"/>
                    <measurement group_id="O2" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2139"/>
                    <measurement group_id="O2" value="1779"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of subjects with SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166"/>
                    <measurement group_id="O2" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with TEAE leading to discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI</title>
        <description>GTI-CWS=Glucocorticoid Toxicity Index Cumulative Worsening Score;&#xD;
GTI-AIS=Glucocorticoid Toxicity Index Aggregate Improvement Score;&#xD;
The Glucocorticoid Toxicity Index (GTI) was developed to score glucocorticoid toxicity. The GTI includes: the Cumulative Worsening Score (CWS) that captures cumulative toxicity, both permanent and transient, over the course of time (serves as a cumulative record of toxicity); and the Aggregate Improvement Score that captures both improvement and worsening of toxicity over time (serves as a record of both improving and worsening toxicity). Both scores range from 0 (best health) to 100 (worst health).</description>
        <time_frame>Baseline, Week 13 and 26</time_frame>
        <population>Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. The number of subjects with data at the specified visit is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI</title>
          <description>GTI-CWS=Glucocorticoid Toxicity Index Cumulative Worsening Score;&#xD;
GTI-AIS=Glucocorticoid Toxicity Index Aggregate Improvement Score;&#xD;
The Glucocorticoid Toxicity Index (GTI) was developed to score glucocorticoid toxicity. The GTI includes: the Cumulative Worsening Score (CWS) that captures cumulative toxicity, both permanent and transient, over the course of time (serves as a cumulative record of toxicity); and the Aggregate Improvement Score that captures both improvement and worsening of toxicity over time (serves as a record of both improving and worsening toxicity). Both scores range from 0 (best health) to 100 (worst health).</description>
          <population>Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. The number of subjects with data at the specified visit is reported.</population>
          <units>Glucocorticoid Toxicity Index</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GTI-CWS (Week 13)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="161"/>
                    <count group_id="O2" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.6" spread="3.41"/>
                    <measurement group_id="O2" value="25.7" spread="3.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GTI-CWS (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.6" spread="3.45"/>
                    <measurement group_id="O2" value="39.7" spread="3.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GTI-AIS (Week 13)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="161"/>
                    <count group_id="O2" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.2" spread="3.46"/>
                    <measurement group_id="O2" value="9.9" spread="3.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GTI-AIS (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.4" spread="3.50"/>
                    <measurement group_id="O2" value="11.2" spread="3.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC</title>
        <description>AC=Adjudication Committee; BVAS=Birmingham Vasculitis Activity Score;&#xD;
The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).</description>
        <time_frame>Week 4</time_frame>
        <population>Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC</title>
          <description>AC=Adjudication Committee; BVAS=Birmingham Vasculitis Activity Score;&#xD;
The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).</description>
          <population>Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.9" lower_limit="61.2" upper_limit="75.9"/>
                    <measurement group_id="O2" value="62.7" lower_limit="54.8" upper_limit="70.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Over 52 Weeks in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36v2 and EQ-5D-5L VAS and Index</title>
        <description>SF-36v2: Measure of health- related quality of life (Medical Outcomes Survey Short Form-36 version 2)&#xD;
EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels&#xD;
The SF-36v2 component scores and the EQ-5D-5L VAS score range from 0 (worst health) to 100 (best health). The EQ-5D-5L Index Score ranges from 0 (worst health) to 1 (best health).</description>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. The number of subjects with data at the specified visit is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Over 52 Weeks in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36v2 and EQ-5D-5L VAS and Index</title>
          <description>SF-36v2: Measure of health- related quality of life (Medical Outcomes Survey Short Form-36 version 2)&#xD;
EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels&#xD;
The SF-36v2 component scores and the EQ-5D-5L VAS score range from 0 (worst health) to 100 (best health). The EQ-5D-5L Index Score ranges from 0 (worst health) to 1 (best health).</description>
          <population>Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. The number of subjects with data at the specified visit is reported.</population>
          <units>Change from baseline</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SF-36v2: Physical Component Score (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.344" spread="0.7432"/>
                    <measurement group_id="O2" value="4.445" spread="0.7332"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Physical Component Score (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.626" spread="0.7505"/>
                    <measurement group_id="O2" value="4.980" spread="0.7435"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Physical Functioning (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.88" spread="1.787"/>
                    <measurement group_id="O2" value="7.31" spread="1.773"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Physical Functioning (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.82" spread="1.809"/>
                    <measurement group_id="O2" value="9.55" spread="1.790"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Role Physical (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.52" spread="2.198"/>
                    <measurement group_id="O2" value="16.78" spread="2.173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Role Physical (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.27" spread="2.228"/>
                    <measurement group_id="O2" value="17.12" spread="2.198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Bodily Pain (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.82" spread="2.197"/>
                    <measurement group_id="O2" value="14.75" spread="2.164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Bodily Pain (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.87" spread="2.220"/>
                    <measurement group_id="O2" value="16.12" spread="2.185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: General Health Perception (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.89" spread="1.428"/>
                    <measurement group_id="O2" value="3.12" spread="1.405"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: General Health Perception (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="1.442"/>
                    <measurement group_id="O2" value="5.84" spread="1.420"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Mental Component Score (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.271" spread="0.8403"/>
                    <measurement group_id="O2" value="4.849" spread="0.8273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Mental Component Score (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.694" spread="0.8491"/>
                    <measurement group_id="O2" value="6.394" spread="0.8406"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Mental Health (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.84" spread="1.331"/>
                    <measurement group_id="O2" value="8.29" spread="1.318"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Mental Health (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.66" spread="1.347"/>
                    <measurement group_id="O2" value="10.89" spread="1.337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Role Emotional (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.40" spread="2.183"/>
                    <measurement group_id="O2" value="7.32" spread="2.158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Role Emotional (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.14" spread="2.212"/>
                    <measurement group_id="O2" value="9.38" spread="2.181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Social Functioning (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.09" spread="2.037"/>
                    <measurement group_id="O2" value="14.50" spread="2.002"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Social Functioning (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.56" spread="2.059"/>
                    <measurement group_id="O2" value="18.06" spread="2.030"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Vitality (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.42" spread="1.751"/>
                    <measurement group_id="O2" value="12.03" spread="1.727"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Vitality (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.48" spread="1.770"/>
                    <measurement group_id="O2" value="14.36" spread="1.750"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L VAS Score (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="1.39"/>
                    <measurement group_id="O2" value="9.1" spread="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L VAS Score (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="1.41"/>
                    <measurement group_id="O2" value="13.0" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L Index Score (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0010" spread="0.01462"/>
                    <measurement group_id="O2" value="0.0229" spread="0.01438"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L Index Score (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0038" spread="0.01471"/>
                    <measurement group_id="O2" value="0.0474" spread="0.01451"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study</title>
        <description>The median time to relapse was not estimable because of small number of relapsed subjects.&#xD;
A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:&#xD;
having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or&#xD;
having achieved BVAS=0 at any time during the treatment period&#xD;
ANCA=anti-neutrophil cytoplasmic autoantibody; BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).</description>
        <time_frame>Week 52</time_frame>
        <population>Intent-to-Treat (ITT) Subjects in the analysis population for the specified treatment group.&#xD;
ITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study</title>
          <description>The median time to relapse was not estimable because of small number of relapsed subjects.&#xD;
A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:&#xD;
having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or&#xD;
having achieved BVAS=0 at any time during the treatment period&#xD;
ANCA=anti-neutrophil cytoplasmic autoantibody; BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).</description>
          <population>Intent-to-Treat (ITT) Subjects in the analysis population for the specified treatment group.&#xD;
ITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="115"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" lower_limit="6.8" upper_limit="19.6"/>
                    <measurement group_id="O2" value="7.5" lower_limit="3.5" upper_limit="13.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period</title>
        <description>The median time to relapse was not estimable because of small number of relapsed subjects.&#xD;
A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:&#xD;
having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or&#xD;
having achieved BVAS=0 at any time during the treatment period&#xD;
The Birmingham Vasculitis Activity Score (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).</description>
        <time_frame>Week 52</time_frame>
        <population>Intent-to-Treat (ITT) Subjects who achieved BVAS=0 during the 52 week treatment period.&#xD;
ITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period</title>
          <description>The median time to relapse was not estimable because of small number of relapsed subjects.&#xD;
A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:&#xD;
having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or&#xD;
having achieved BVAS=0 at any time during the treatment period&#xD;
The Birmingham Vasculitis Activity Score (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).</description>
          <population>Intent-to-Treat (ITT) Subjects who achieved BVAS=0 during the 52 week treatment period.&#xD;
ITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.0" lower_limit="14.9" upper_limit="28.2"/>
                    <measurement group_id="O2" value="10.1" lower_limit="5.9" upper_limit="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks</title>
        <description>Change from baseline in kidney function, as measured by eGFR (based on the MDRD equation), was measured in subjects with renal disease based on the BVAS renal component.&#xD;
eGFR=estimated glomerular filtration rate&#xD;
BVAS=Birmingham Vasculitis Activity Score&#xD;
MDRD=Modification of Diet in Renal Disease</description>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Intent-to-Treat (ITT) Subjects With Renal Disease at Baseline (based on BVAS).&#xD;
ITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks</title>
          <description>Change from baseline in kidney function, as measured by eGFR (based on the MDRD equation), was measured in subjects with renal disease based on the BVAS renal component.&#xD;
eGFR=estimated glomerular filtration rate&#xD;
BVAS=Birmingham Vasculitis Activity Score&#xD;
MDRD=Modification of Diet in Renal Disease</description>
          <population>Intent-to-Treat (ITT) Subjects With Renal Disease at Baseline (based on BVAS).&#xD;
ITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
          <units>Change in eGFR (mL/min/1.73 m^2)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
                <count group_id="O2" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" lower_limit="0.9" upper_limit="4.9"/>
                    <measurement group_id="O2" value="5.8" lower_limit="3.7" upper_limit="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" lower_limit="2.1" upper_limit="6.1"/>
                    <measurement group_id="O2" value="7.3" lower_limit="5.2" upper_limit="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks</title>
        <description>BVAS=Birmingham Vasculitis Activity Score&#xD;
UACR=Urinary albumin:creatinine ratio</description>
        <time_frame>Baseline, Week 4, 26 and 52</time_frame>
        <population>Intent-to-Treat (ITT) Subjects With Renal Disease (based on BVAS) and Albuminuria (UACR&gt;=10 mg/g creatinine) at Baseline&#xD;
ITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks</title>
          <description>BVAS=Birmingham Vasculitis Activity Score&#xD;
UACR=Urinary albumin:creatinine ratio</description>
          <population>Intent-to-Treat (ITT) Subjects With Renal Disease (based on BVAS) and Albuminuria (UACR&gt;=10 mg/g creatinine) at Baseline&#xD;
ITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
          <units>Percentage change</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-16" upper_limit="19"/>
                    <measurement group_id="O2" value="-40" lower_limit="-50" upper_limit="-28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-70" lower_limit="-75" upper_limit="-65"/>
                    <measurement group_id="O2" value="-63" lower_limit="-69" upper_limit="-56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-77" lower_limit="-81" upper_limit="-72"/>
                    <measurement group_id="O2" value="-74" lower_limit="-78" upper_limit="-69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks</title>
        <description>BVAS=Birmingham Vasculitis Activity Score&#xD;
MCP-1=monocyte chemoattractant protein-1</description>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Intent-to-Treat (ITT) Subjects With Renal Disease at Baseline (based on BVAS).&#xD;
ITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks</title>
          <description>BVAS=Birmingham Vasculitis Activity Score&#xD;
MCP-1=monocyte chemoattractant protein-1</description>
          <population>Intent-to-Treat (ITT) Subjects With Renal Disease at Baseline (based on BVAS).&#xD;
ITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
          <units>Percentage change</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-64" lower_limit="-67" upper_limit="-59"/>
                    <measurement group_id="O2" value="-67" lower_limit="-70" upper_limit="-63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-71" lower_limit="-74" upper_limit="-67"/>
                    <measurement group_id="O2" value="-73" lower_limit="-76" upper_limit="-70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points</title>
        <description>VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health).</description>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points</title>
          <description>VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health).</description>
          <population>Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="0.092"/>
                    <measurement group_id="O2" value="1.06" spread="0.090"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="151"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.15" spread="0.093"/>
                    <measurement group_id="O2" value="1.17" spread="0.091"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5)</title>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5)</title>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
          <units>10^3 cells/μL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="151"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Leukocytes (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="151"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.69" spread="0.338"/>
                    <measurement group_id="O2" value="-5.94" spread="0.387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.54" spread="0.365"/>
                    <measurement group_id="O2" value="-5.62" spread="0.395"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.10" spread="0.338"/>
                    <measurement group_id="O2" value="-5.24" spread="0.380"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.89" spread="0.361"/>
                    <measurement group_id="O2" value="-4.95" spread="0.372"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.62" spread="0.090"/>
                    <measurement group_id="O2" value="-0.84" spread="0.099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.67" spread="0.090"/>
                    <measurement group_id="O2" value="-0.82" spread="0.100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5)</title>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5)</title>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Eosinophils (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.016"/>
                    <measurement group_id="O2" value="0.07" spread="0.018"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.013"/>
                    <measurement group_id="O2" value="0.07" spread="0.019"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.004"/>
                    <measurement group_id="O2" value="-0.00" spread="0.004"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.004"/>
                    <measurement group_id="O2" value="-0.01" spread="0.004"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.022"/>
                    <measurement group_id="O2" value="-0.04" spread="0.024"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.024"/>
                    <measurement group_id="O2" value="-0.01" spread="0.026"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-73.9" spread="8.49"/>
                    <measurement group_id="O2" value="-77.1" spread="9.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-75.5" spread="8.01"/>
                    <measurement group_id="O2" value="-73.8" spread="9.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5)</title>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5)</title>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
          <units>10^12 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Erythrocytes (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.226" spread="0.0450"/>
                    <measurement group_id="O2" value="0.252" spread="0.0432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.244" spread="0.0410"/>
                    <measurement group_id="O2" value="0.279" spread="0.0432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5)</title>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5)</title>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.07" spread="0.129"/>
                    <measurement group_id="O2" value="1.10" spread="0.120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.20" spread="0.126"/>
                    <measurement group_id="O2" value="1.27" spread="0.125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5)</title>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5)</title>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
          <units>percentage of red blood cells</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hematocrit (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="0.38"/>
                    <measurement group_id="O2" value="2.7" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="0.37"/>
                    <measurement group_id="O2" value="3.2" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2)</title>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2)</title>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="154"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lactate Dehydrogenase (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="145"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="5.68"/>
                    <measurement group_id="O2" value="-6.1" spread="5.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lactate Dehydrogenase (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="141"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.6" spread="5.33"/>
                    <measurement group_id="O2" value="-10.7" spread="4.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline Phosphatase (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="2.47"/>
                    <measurement group_id="O2" value="-3.9" spread="2.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline Phosphatase (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.77"/>
                    <measurement group_id="O2" value="-4.0" spread="2.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.6" spread="5.27"/>
                    <measurement group_id="O2" value="76.8" spread="10.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.6" spread="5.67"/>
                    <measurement group_id="O2" value="76.3" spread="9.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Aminotransferase (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.8" spread="1.77"/>
                    <measurement group_id="O2" value="-6.1" spread="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Aminotransferase (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.2" spread="1.57"/>
                    <measurement group_id="O2" value="-7.2" spread="1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="0.98"/>
                    <measurement group_id="O2" value="2.5" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.85"/>
                    <measurement group_id="O2" value="2.0" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2)</title>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2)</title>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Creatinine (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.105" spread="0.0569"/>
                    <measurement group_id="O2" value="-0.195" spread="0.0508"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.200" spread="0.0416"/>
                    <measurement group_id="O2" value="-0.244" spread="0.0627"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea Nitrogen (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.4" spread="1.16"/>
                    <measurement group_id="O2" value="-11.0" spread="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea Nitrogen (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.8" spread="1.11"/>
                    <measurement group_id="O2" value="-11.9" spread="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" spread="50"/>
                    <measurement group_id="O2" value="220" spread="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="160" spread="48"/>
                    <measurement group_id="O2" value="250" spread="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0" spread="4.27"/>
                    <measurement group_id="O2" value="7.4" spread="3.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.8" spread="4.28"/>
                    <measurement group_id="O2" value="9.3" spread="4.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL Cholesterol (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.7" spread="3.66"/>
                    <measurement group_id="O2" value="12.0" spread="3.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL Cholesterol (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="159"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7" spread="3.48"/>
                    <measurement group_id="O2" value="11.9" spread="3.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.065" spread="0.0182"/>
                    <measurement group_id="O2" value="0.078" spread="0.0250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.053" spread="0.0185"/>
                    <measurement group_id="O2" value="0.057" spread="0.0201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vital Signs (1/5)</title>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Signs (1/5)</title>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="154"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Blood Pressure (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" spread="1.70"/>
                    <measurement group_id="O2" value="-2.6" spread="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic Blood Pressure (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="151"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" spread="1.64"/>
                    <measurement group_id="O2" value="-1.0" spread="1.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="0.98"/>
                    <measurement group_id="O2" value="0.5" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="151"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.01"/>
                    <measurement group_id="O2" value="1.4" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vital Signs (2/5)</title>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Signs (2/5)</title>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.</population>
          <units>beats/min</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pulse Rate (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="1.12"/>
                    <measurement group_id="O2" value="0.9" spread="1.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse Rate (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="151"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="1.07"/>
                    <measurement group_id="O2" value="-0.3" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vital Signs (3/5)</title>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Signs (3/5)</title>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
          <units>degree Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Temperature (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.043"/>
                    <measurement group_id="O2" value="-0.11" spread="0.046"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.044"/>
                    <measurement group_id="O2" value="-0.11" spread="0.048"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vital Signs (4/5)</title>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Signs (4/5)</title>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
          <units>kilogram(s)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="154"/>
                <count group_id="O2" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Weight (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.33" spread="0.397"/>
                    <measurement group_id="O2" value="1.93" spread="0.369"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="151"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.27" spread="0.477"/>
                    <measurement group_id="O2" value="2.59" spread="0.487"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vital Signs (5/5)</title>
        <description>BMI=Body Mass Index</description>
        <time_frame>Baseline, Week 26 and 52</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Signs (5/5)</title>
          <description>BMI=Body Mass Index</description>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.</population>
          <units>kilogram(s)/ square meter</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BMI (Week 26)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                    <count group_id="O2" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.13" spread="0.135"/>
                    <measurement group_id="O2" value="0.67" spread="0.132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BMI (Week 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.12" spread="0.164"/>
                    <measurement group_id="O2" value="0.94" spread="0.179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Clinically Significant ECG Changes From Baseline</title>
        <description>Clinical significance was assessed by the individual reading of the ECGs&#xD;
ECG=Electrocardiogram</description>
        <time_frame>From day 1 throughout the study period (day 421/week 60)</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Clinically Significant ECG Changes From Baseline</title>
          <description>Clinical significance was assessed by the individual reading of the ECGs&#xD;
ECG=Electrocardiogram</description>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.</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="164"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Where a Relationship Between Avacopan/Placebo, Glucocorticoid Use, Cyclophosphamide, Rituximab, and Azathioprine or Mycophenolate Use to an AE Was Determined by the Investigator</title>
        <description>AE=Adverse Event</description>
        <time_frame>From day 1 throughout the study period (day 421/week 60)</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Where a Relationship Between Avacopan/Placebo, Glucocorticoid Use, Cyclophosphamide, Rituximab, and Azathioprine or Mycophenolate Use to an AE Was Determined by the Investigator</title>
          <description>AE=Adverse Event</description>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.</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="164"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Relationship of avacopan/placebo to an AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relationship of glucocorticoid use to an AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                    <measurement group_id="O2" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relationship of cyclophosphamide IV use to an AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relationship of oral cyclophosphamide use to an AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relationship of rituximab use to an AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relationship of azathioprine use to an AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relationship of mycophenolate use to an AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity</title>
        <description>WBC=White Blood Cell&#xD;
TEAE=Treatment-Emergent Adverse Event</description>
        <time_frame>From day 1 throughout the study period (day 421/week 60)</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity</title>
          <description>WBC=White Blood Cell&#xD;
TEAE=Treatment-Emergent Adverse Event</description>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.</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="164"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Treatment-Emergent Infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124"/>
                    <measurement group_id="O2" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Serious Treatment-Emergent Infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Severe Treatment-Emergent Infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Treatment-Emergent Infection Leading to Study Withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Treatment-Emergent Life-threatening Infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Treatment-Emergent Infection Leading to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE Associated with Hepatic Abnormalities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE Associated with Low WBC Counts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE Associated with hypersensitivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study</title>
        <description>BVAS=Birmingham Vasculitis Activity Score;&#xD;
A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:&#xD;
having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or&#xD;
having achieved BVAS=0 at any time during the treatment period&#xD;
The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).</description>
        <time_frame>From day 1 throughout the study period (day 421/week 60)</time_frame>
        <population>Intended-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone Group</title>
            <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study</title>
          <description>BVAS=Birmingham Vasculitis Activity Score;&#xD;
A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:&#xD;
having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or&#xD;
having achieved BVAS=0 at any time during the treatment period&#xD;
The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).</description>
          <population>Intended-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.</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="157"/>
                <count group_id="O2" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From day 1 throughout the study period (day 421/week 60)</time_frame>
      <desc>An AE was considered treatment-emergent if the start date/time of the event was on or after the date/time of first dose of study drug through 56 days following the last dose administered during the randomized treatment period.</desc>
      <group_list>
        <group group_id="E1">
          <title>Prednisone Group</title>
          <description>Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone. The safety population included all subjects who were randomized and had received at least one dose of study drug.</description>
        </group>
        <group group_id="E2">
          <title>Avacopan Group</title>
          <description>Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo. The safety population included all subjects who were randomized and had received at least one dose of study drug.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</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="4" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="74" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="70" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Agranulocytosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Bone marrow failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Bone marrow toxicity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Granulomatous lymphadenitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Atrioventricular block first degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Episcleritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Vasculitis gastrointestinal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Rectal prolapse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Small intestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="164"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Hepatitis cholestatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Hepatocellular injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Anti-neutrophil cytoplasmic antibody positive vasculitis</sub_title>
                <counts group_id="E1" events="25" subjects_affected="20" subjects_at_risk="164"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="164"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Campylobacter gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Hepatitis B</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airways disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Pneumonia haemophilus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Post procedural sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Aspergillus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Cryptococcosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Meningitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Ophthalmic herpes simplex</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Parainfluenzae virus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Pneumonia cytomegaloviral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Multiple fractures</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Procedural vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="164"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Antineutrophil cytoplasmic antibody increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Medical observation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Polymyalgia rheumatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Chondrocalcinosis pyrophosphate</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Carcinoma in situ of skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Mononeuropathy multiplex</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Nervous system disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Somatic symptom disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Glomerulonephritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>End stage renal disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary alveolar haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Bronchopneumopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Orthopnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Laryngeal stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Nasal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Pharyngeal ulceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Pneumomediastinum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Pulmonary arterial hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Skin necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula operation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Granulomatosis with polyangiitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Microscopic polyangiitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</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="161" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="164" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="19" subjects_affected="18" subjects_at_risk="164"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="14" subjects_at_risk="164"/>
                <counts group_id="E2" events="15" subjects_affected="12" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Increased tendency to bruise</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="164"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="27" subjects_affected="18" subjects_at_risk="164"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Cushingoid</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="164"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="46" subjects_affected="34" subjects_at_risk="164"/>
                <counts group_id="E2" events="54" subjects_affected="39" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="31" subjects_affected="24" subjects_at_risk="164"/>
                <counts group_id="E2" events="33" subjects_affected="25" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="27" subjects_affected="21" subjects_at_risk="164"/>
                <counts group_id="E2" events="29" subjects_affected="25" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="164"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="164"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="164"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="17" subjects_affected="13" subjects_at_risk="164"/>
                <counts group_id="E2" events="26" subjects_affected="19" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="164"/>
                <counts group_id="E2" events="15" subjects_affected="10" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="164"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="56" subjects_affected="40" subjects_at_risk="164"/>
                <counts group_id="E2" events="39" subjects_affected="35" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="164"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="25" subjects_affected="19" subjects_at_risk="164"/>
                <counts group_id="E2" events="18" subjects_affected="15" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anti-neutrophil cytoplasmic antibody positive vasculitis</sub_title>
                <description>Worsening of vasculitis is reported as the Preferred Term of &quot;anti-neutrophil cytoplasmic antibody-positive vasculitis&quot;.</description>
                <counts group_id="E1" events="46" subjects_affected="34" subjects_at_risk="164"/>
                <counts group_id="E2" events="30" subjects_affected="26" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="46" subjects_affected="30" subjects_at_risk="164"/>
                <counts group_id="E2" events="38" subjects_affected="25" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="33" subjects_affected="24" subjects_at_risk="164"/>
                <counts group_id="E2" events="28" subjects_affected="24" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="33" subjects_affected="23" subjects_at_risk="164"/>
                <counts group_id="E2" events="19" subjects_affected="12" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="164"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="164"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="164"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="19" subjects_affected="17" subjects_at_risk="164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="164"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="21" subjects_affected="20" subjects_at_risk="164"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="48" subjects_affected="36" subjects_at_risk="164"/>
                <counts group_id="E2" events="42" subjects_affected="31" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="47" subjects_affected="37" subjects_at_risk="164"/>
                <counts group_id="E2" events="23" subjects_affected="18" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="164"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="25" subjects_affected="22" subjects_at_risk="164"/>
                <counts group_id="E2" events="17" subjects_affected="16" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="164"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="30" subjects_affected="23" subjects_at_risk="164"/>
                <counts group_id="E2" events="43" subjects_affected="34" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="164"/>
                <counts group_id="E2" events="14" subjects_affected="11" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="164"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="164"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="27" subjects_affected="25" subjects_at_risk="164"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="166"/>
              </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="29" subjects_affected="26" subjects_at_risk="164"/>
                <counts group_id="E2" events="31" subjects_affected="26" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="30" subjects_affected="21" subjects_at_risk="164"/>
                <counts group_id="E2" events="21" subjects_affected="14" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="14" subjects_affected="11" subjects_at_risk="164"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="166"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="164"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="31" subjects_affected="29" subjects_at_risk="164"/>
                <counts group_id="E2" events="36" subjects_affected="30" subjects_at_risk="166"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The PI shall provide Sponsor with an advance copy of any proposed publication or oral presentation at least 60 days prior to the planned date of submission or presentation and Sponsor shall have 60 days to review the proposed publication. Sponsor may request in writing, and the PI shall agree to, (a) the deletion of any Confidential Information, (b) any reasonable changes requested by Sponsor, or (c) a delay of such proposed submission for an additional period, not to exceed 90 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical trial disclosure</name_or_title>
      <organization>ChemoCentryx, Inc.</organization>
      <phone>650.210.2900</phone>
      <email>clinicaltrials@chemocentryx.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/NCT02994927
org study id: CL010_168
secondary id: ADVOCATE
nct id: NCT02994927
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain
      remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated
      vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or
      in combination with rituximab.
Complement 5a and its receptor C5aR (CD88) are involved in the pathogenesis of
      anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

      This is a randomized, double-blind, active-controlled Phase 3 study to evaluate the safety
      and efficacy of the orally-administered, selective C5aR inhibitor CCX168 (avacopan) in
      inducing and sustaining remission in patients with anti-neutrophil cytoplasmic antibody
      (ANCA)-associated vasculitis (AAV) treated concomitantly with Rituximab or
      Cyclophosphamide/Azathioprine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: This study was double-blind, double-dummy, i.e., placebo capsules were identical in appearance to the avacopan capsules, and prednisone capsules also had matching placebo capsules. To maintain the blind, multiple measures were taken (i.e., randomization code was not accessible to study personnel who had contact with study centers or who were involved in data management and analysis for the duration of the study).
measure: Percentage of Subjects Achieving Disease Remission at Week 26
time frame: Week 26
description: Disease remission at Week 26 was defined as:
Achieving a BVAS of 0 as determined by the Adjudication Committee;
No administration of glucocorticoids given for ANCA-associated vasculitis within 4 weeks prior to Week 26;
No BVAS >0 during the 4 weeks prior to Week 26 (if collected for an unscheduled assessment).
measure: Percentage of Subjects Achieving Sustained Disease Remission at Week 52
time frame: Week 52
description: Sustained remission at Week 52 was defined as:
Disease remission at Week 26 as defined above;
Disease remission at Week 52 defined as a BVAS of 0 at Week 52 as determined by the Adjudication Committee and no administration of glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 52;
No disease relapse between Week 26 and Week 52 as determined by the Adjudication Committee.
measure: Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs
time frame: From day 1 throughout the study period (day 421/week 60)
description: AEs=Adverse events
SAEs=Serious adverse events
TEAE=Treatment-emergent adverse event
measure: Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI
time frame: Baseline, Week 13 and 26
description: GTI-CWS=Glucocorticoid Toxicity Index Cumulative Worsening Score;
GTI-AIS=Glucocorticoid Toxicity Index Aggregate Improvement Score;
The Glucocorticoid Toxicity Index (GTI) was developed to score glucocorticoid toxicity. The GTI includes: the Cumulative Worsening Score (CWS) that captures cumulative toxicity, both permanent and transient, over the course of time (serves as a cumulative record of toxicity); and the Aggregate Improvement Score that captures both improvement and worsening of toxicity over time (serves as a record of both improving and worsening toxicity). Both scores range from 0 (best health) to 100 (worst health).
measure: Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC
time frame: Week 4
description: AC=Adjudication Committee; BVAS=Birmingham Vasculitis Activity Score;
The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).
measure: Change From Baseline Over 52 Weeks in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36v2 and EQ-5D-5L VAS and Index
time frame: Baseline, Week 26 and 52
description: SF-36v2: Measure of health- related quality of life (Medical Outcomes Survey Short Form-36 version 2)
EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels
The SF-36v2 component scores and the EQ-5D-5L VAS score range from 0 (worst health) to 100 (best health). The EQ-5D-5L Index Score ranges from 0 (worst health) to 1 (best health).
measure: Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study
time frame: Week 52
description: The median time to relapse was not estimable because of small number of relapsed subjects.
A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:
having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or
having achieved BVAS=0 at any time during the treatment period
ANCA=anti-neutrophil cytoplasmic autoantibody; BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).
measure: Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period
time frame: Week 52
description: The median time to relapse was not estimable because of small number of relapsed subjects.
A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:
having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or
having achieved BVAS=0 at any time during the treatment period
The Birmingham Vasculitis Activity Score (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).
measure: In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks
time frame: Baseline, Week 26 and 52
description: Change from baseline in kidney function, as measured by eGFR (based on the MDRD equation), was measured in subjects with renal disease based on the BVAS renal component.
eGFR=estimated glomerular filtration rate
BVAS=Birmingham Vasculitis Activity Score
MDRD=Modification of Diet in Renal Disease
measure: In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks
time frame: Baseline, Week 4, 26 and 52
description: BVAS=Birmingham Vasculitis Activity Score
UACR=Urinary albumin:creatinine ratio
measure: In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks
time frame: Baseline, Week 26 and 52
description: BVAS=Birmingham Vasculitis Activity Score
MCP-1=monocyte chemoattractant protein-1
measure: Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points
time frame: Baseline, Week 26 and 52
description: VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health).
measure: Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5)
time frame: Baseline, Week 26 and 52
measure: Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5)
time frame: Baseline, Week 26 and 52
measure: Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5)
time frame: Baseline, Week 26 and 52
measure: Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5)
time frame: Baseline, Week 26 and 52
measure: Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5)
time frame: Baseline, Week 26 and 52
measure: Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2)
time frame: Baseline, Week 26 and 52
measure: Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2)
time frame: Baseline, Week 26 and 52
measure: Change From Baseline in Vital Signs (1/5)
time frame: Baseline, Week 26 and 52
measure: Change From Baseline in Vital Signs (2/5)
time frame: Baseline, Week 26 and 52
measure: Change From Baseline in Vital Signs (3/5)
time frame: Baseline, Week 26 and 52
measure: Change From Baseline in Vital Signs (4/5)
time frame: Baseline, Week 26 and 52
measure: Change From Baseline in Vital Signs (5/5)
time frame: Baseline, Week 26 and 52
description: BMI=Body Mass Index
measure: Number of Subjects With Clinically Significant ECG Changes From Baseline
time frame: From day 1 throughout the study period (day 421/week 60)
description: Clinical significance was assessed by the individual reading of the ECGs
ECG=Electrocardiogram
measure: Number of Subjects Where a Relationship Between Avacopan/Placebo, Glucocorticoid Use, Cyclophosphamide, Rituximab, and Azathioprine or Mycophenolate Use to an AE Was Determined by the Investigator
time frame: From day 1 throughout the study period (day 421/week 60)
description: AE=Adverse Event
measure: Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity
time frame: From day 1 throughout the study period (day 421/week 60)
description: WBC=White Blood Cell
TEAE=Treatment-Emergent Adverse Event
measure: Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study
time frame: From day 1 throughout the study period (day 421/week 60)
description: BVAS=Birmingham Vasculitis Activity Score;
A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:
having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or
having achieved BVAS=0 at any time during the treatment period
The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).
arm group label: Prednisone group
arm group type: Active Comparator
description: Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.
arm group label: Avacopan group
arm group type: Experimental
description: Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.
intervention type: Drug
intervention name: Avacopan
description: Avacopan 30 mg twice daily orally for 52 weeks (364 days):
- Three 10 mg avacopan capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose.
Oral prednisone-matching placebo tapering regimen over 20 weeks (140 days):
Prednisone-matching placebo capsules equivalent to 60 mg per day if the subject's body weight was ≥55 kg, or 45 mg per day if the subject's body weight was <55 kg, starting on Day 1 with tapering according to a protocol-specified schedule.
Adolescents who weighed ≤37 kg started at a prednisone-matching placebo dose of 30 mg per day.
arm group label: Avacopan group
other name: CCX168
intervention type: Drug
intervention name: Prednisone
description: Avacopan-matching placebo twice daily orally for 52 weeks (364 days):
- Three avacopan-matching placebo capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose.
Oral prednisone tapering regimen over 20 weeks (140 days):
Prednisone 60 mg per day if the subject's body weight was ≥55 kg, or 45 mg per day if the subject's body weight was <55 kg, starting on Day 1 with tapering according to the protocol-specified schedule.
Adolescents who weighed ≤37 kg started at a prednisone dose of 30 mg per day.
arm group label: Prednisone group
intervention type: Drug
intervention name: Cyclophosphamide
description: Orally or intravenously administered
arm group label: Avacopan group
arm group label: Prednisone group
intervention type: Biological
intervention name: Rituximab
description: Intravenously administered
arm group label: Avacopan group
arm group label: Prednisone group
intervention type: Drug
intervention name: Azathioprine
description: Orally administered
arm group label: Avacopan group
arm group label: Prednisone group
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: Australia
country: Austria
country: Belgium
country: Canada
country: Czechia
country: Denmark
country: France
country: Germany
country: Hungary
country: Ireland
country: Italy
country: Japan
country: Netherlands
country: New Zealand
country: Norway
country: Spain
country: Sweden
country: Switzerland
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Vasculitis
mesh term: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
mesh term: Prednisone
mesh term: Cyclophosphamide
mesh term: Rituximab
mesh term: Azathioprine
sharing ipd: Yes
ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
ipd url: http://www.amgen.com/datasharing
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 