<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/NCT03782376</url>
  </required_header>
  <id_info>
    <org_study_id>CR108533</org_study_id>
    <secondary_id>2018-002629-51</secondary_id>
    <secondary_id>CNTO1275CRD3008</secondary_id>
    <nct_id>NCT03782376</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease</brief_title>
  <acronym>POWER</acronym>
  <official_title>A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen-Cilag Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen-Cilag Ltd.</source>
  <oversight_info>
    <has_dmc>No</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 purpose of this study is to evaluate the efficacy and safety of a single&#xD;
      intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg)&#xD;
      ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every&#xD;
      8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study compares the efficacy and safety of a single weight-tiered based IV re-induction&#xD;
      dose of approximately 6 mg/kg ustekinumab versus continuing with regular SC q8w 90 mg&#xD;
      ustekinumab administration. It consists of screening (5 weeks); treatment period (Week 0 to&#xD;
      24); and safety follow up visit (20 weeks after last dose). The primary hypothesis is that a&#xD;
      single IV re-induction dose of ustekinumab is superior to continuing with regular SC q8w&#xD;
      maintenance treatment as measured by clinical response after 16 weeks of treatment. Study&#xD;
      assessments will include Crohn's disease activity index (CDAI), video ileocolonoscopy,&#xD;
      patient-reported outcomes (PROs), laboratory evaluations, biomarkers, review of concomitant&#xD;
      medications and adverse events (AEs), and evaluation of serum concentrations of study agent&#xD;
      as well as development of antibodies to study agent. All participants will be randomly&#xD;
      assigned to receive either ustekinumab IV re-induction or regular SC q8w 90 mg ustekinumab&#xD;
      injection at baseline in a double dummy design. No participants will be treated with placebo&#xD;
      only.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">January 10, 2023</completion_date>
  <primary_completion_date type="Actual">August 19, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Clinical Response at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>Clinical response was defined as greater than or equal to (&gt;=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score &lt; 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Clinical Remission at Weeks 8, 16, and 24</measure>
    <time_frame>Weeks 8, 16, and 24</time_frame>
    <description>Percentage of participants with clinical remission at Weeks 8, 16, and 24 were reported. Clinical remission was defined as CDAI score of &lt;150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Clinical Response at Weeks 8 and 24</measure>
    <time_frame>Weeks 8 and 24</time_frame>
    <description>Clinical response was defined as a &gt;=100-point reduction from the baseline in CDAI score or a CDAI score &lt;150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Weeks 16 and 24</measure>
    <time_frame>Weeks 16 and 24</time_frame>
    <description>Percentage of participants with normalization at Weeks 16 and 24, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (&lt;=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as &lt;=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>From baseline (Week 0) up to Week 36</time_frame>
    <description>An adverse event was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. TEAEs were adverse events with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. In this outcome measure, TEAEs including all AEs irrespective of being serious or non-serious AE are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)</measure>
    <time_frame>From baseline (Week 0) up to Week 36</time_frame>
    <description>A serious adverse event (SAE) was an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; a suspected transmission of any infectious agent via a medicinal product; medically important. TESAEs were adverse events with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Treatment-emergent Infections</measure>
    <time_frame>From baseline (Week 0) up to Week 36</time_frame>
    <description>Percentage of participants with treatment-emergent infections were reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Treatment-emergent Serious Infections</measure>
    <time_frame>From baseline (Week 0) up to Week 36</time_frame>
    <description>Percentage of participants with treatment-emergent serious infections was reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein)</measure>
    <time_frame>Baseline, Weeks 8, 16, 24</time_frame>
    <description>Change from baseline in clinical laboratory values for hematology (hemoglobin) and chemistry (albumin, total protein) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit)</measure>
    <time_frame>Baseline, Weeks 8, 16, 24</time_frame>
    <description>Change from baseline in clinical laboratory values for hematology (hematocrit) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets)</measure>
    <time_frame>Baseline, Weeks 8, 16, 24</time_frame>
    <description>Change from baseline in clinical laboratory values for hematology (total WBC, neutrophils, absolute lymphocyte, eosinophils, platelets) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST])</measure>
    <time_frame>Baseline, Weeks 8, 16, 24</time_frame>
    <description>Change from baseline in clinical laboratory values for chemistry (alkaline, ALT, AST) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine)</measure>
    <time_frame>Baseline, Weeks 8, 16, 24</time_frame>
    <description>Change from baseline in clinical laboratory values for chemistry (total bilirubin, direct bilirubin, creatinine) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate)</measure>
    <time_frame>Baseline, Weeks 8, 16, 24</time_frame>
    <description>Change from baseline in clinical laboratory values for chemistry (sodium, potassium, chloride, BUN/urea, calcium, phosphate) was reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">215</enrollment>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>Group 1: Ustekinumab (IV re-induction)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who experience a secondary loss of response (LoR) to 90 mg ustekinumab maintenance treatment, administered subcutaneously every 8 weeks (q8w) will receive a weight-tiered based ustekinumab IV re-induction dose of approximately 6 mg/kg and matching placebo subcutaneously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Ustekinumab (Continuous q8w SC maintenance)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants who experience a secondary LoR to 90 mg ustekinumab maintenance treatment, administered subcutaneously q8w will receive ustekinumab 90 mg subcutaneously and matching placebo intravenously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ustekinumab approximately 6 mg/kg (IV)</intervention_name>
    <description>Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0.</description>
    <arm_group_label>Group 1: Ustekinumab (IV re-induction)</arm_group_label>
    <other_name>STELARA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (SC)</intervention_name>
    <description>Participants will receive SC injection of placebo at Week 0.</description>
    <arm_group_label>Group 1: Ustekinumab (IV re-induction)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (IV)</intervention_name>
    <description>Participants will receive IV infusion of placebo at Week 0.</description>
    <arm_group_label>Group 2: Ustekinumab (Continuous q8w SC maintenance)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ustekinumab 90 mg (SC) Group 1</intervention_name>
    <description>Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16.</description>
    <arm_group_label>Group 1: Ustekinumab (IV re-induction)</arm_group_label>
    <other_name>STELARA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ustekinumab 90 mg (SC) Group 2</intervention_name>
    <description>Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16.</description>
    <arm_group_label>Group 2: Ustekinumab (Continuous q8w SC maintenance)</arm_group_label>
    <other_name>STELARA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  A history of Crohn's disease or fistulizing Crohn's disease of at least 3 months'&#xD;
             duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by&#xD;
             radiography, histology, and/or endoscopy&#xD;
&#xD;
          -  Currently receiving subcutaneous 90 mg every 8 weeks (q8w) ustekinumab maintenance&#xD;
             therapy and initially responded to ustekinumab induction therapy, administered&#xD;
             according to the local label, followed by secondary loss of response (LoR) to&#xD;
             ustekinumab. Secondary LoR to ustekinumab is defined as active disease at study&#xD;
             baseline, proven by a Crohn's Disease Activity Index (CDAI) score of greater than or&#xD;
             equal to (&gt;=) 220 and &lt;=450 with at least one of the following: Elevated C-reactive&#xD;
             protein (CRP) (&gt;3.0 milligram per liter [mg/L]); and/or elevated Fecal calprotectin&#xD;
             (fCal) &gt;250 milligram per kilogram [mg/kg]); and/or endoscopy (performed less than or&#xD;
             equal to (&lt;=) 3 months before baseline) with evidence of active Crohn's disease,&#xD;
             (defined as one or more ulcerations in the ileum and/or colon)&#xD;
&#xD;
          -  Participants receiving either oral 5-aminosalicylic acid (5-ASA) compounds, oral&#xD;
             corticosteroids (for example {e.g.}, prednisone, budesonide) at a&#xD;
             prednisone-equivalent dose of &lt;=40 mg/day or &lt;=9 mg/day of budesonide, antibiotics&#xD;
             used as the primary treatment of Crohn's disease, or conventional immunomodulators&#xD;
             (i.e., azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]) are&#xD;
             permitted providing the doses indicated are stable before baseline or have been&#xD;
             discontinued before baseline within the protocol defined durations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complications of Crohn's disease, such as symptomatic strictures or stenoses, short&#xD;
             gut syndrome, or any other manifestation that might be anticipated to require surgery,&#xD;
             could preclude the use of the CDAI to assess response to therapy, or would possibly&#xD;
             confound the ability to assess the effect of treatment with ustekinumab&#xD;
&#xD;
          -  Currently has or is suspected to have an abscess. Recent cutaneous and perianal&#xD;
             abscesses are not exclusionary if drained and adequately treated at least 3 weeks&#xD;
             before baseline (or 8 weeks before baseline for intra-abdominal abscesses) provided&#xD;
             there is no anticipated need for any further surgery. Participants with active&#xD;
             fistulas may be included if there is no anticipation of a need for surgery and there&#xD;
             are currently no abscesses identified&#xD;
&#xD;
          -  Any kind of bowel resection within 6 months or any other intra-abdominal surgery&#xD;
             within 3 months before baseline&#xD;
&#xD;
          -  A draining (i.e., functioning) stoma or ostomy&#xD;
&#xD;
          -  Received ustekinumab intravenous re-induction after the initial weight-tiered-based IV&#xD;
             induction dose of ustekinumab&#xD;
&#xD;
          -  Any known history of shortened frequency of SC dose administration (&lt;q8w) for a&#xD;
             secondary loss of response where the participant did not, in the opinion of the&#xD;
             treating physician, benefit from the dose interval shortening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen-Cilag Ltd. Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen-Cilag Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peak Gastroenterology Associates</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Research Network, LLC</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advent Health</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital Tampa</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph's</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342-5020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Gastroenterology Specialists</name>
      <address>
        <city>Suwanee</city>
        <state>Georgia</state>
        <zip>30024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Chandler Medical Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chevy Chase Clinical Research</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham &amp; Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Hospital</name>
      <address>
        <city>Hilliard</city>
        <state>Ohio</state>
        <zip>43026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northshore Gastroenterology Research, LLC</name>
      <address>
        <city>Westlake</city>
        <state>Ohio</state>
        <zip>44145</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Digestive Disease Specialists</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Digestive Disease Consultants</name>
      <address>
        <city>Cedar Park</city>
        <state>Texas</state>
        <zip>78613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-2740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Research of America, LLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tyler Research Institute, LLC</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Gastroenterology, PLLC</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus der Barmherzigen Brüder</name>
      <address>
        <city>Wien</city>
        <zip>1020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Wien</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hepato-gastroenterologie HK, s.r.o.</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 12</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ISCARE a.s.</name>
      <address>
        <city>Praha 9</city>
        <zip>190 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Beaujon</name>
      <address>
        <city>Clichy</city>
        <zip>92110</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille - Hopital Claude Huriez</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Montpellier - Hopital Saint-Eloi</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hopital Saint Antoine</name>
      <address>
        <city>Paris cedex 12</city>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospices Civils de Lyon HCL</name>
      <address>
        <city>Pierre Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Hopital de Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nancy_ Hopital Brabois</name>
      <address>
        <city>Vandoeuvre-les-Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Augsburg</name>
      <address>
        <city>Augsburg</city>
        <zip>D-86158</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GASTRO-Studien</name>
      <address>
        <city>Berlin</city>
        <zip>10825</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Universitatsmedizin Berlin (CCM)</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinisches Versorgungszentrum (MVZ) Dachau</name>
      <address>
        <city>Dachau</city>
        <zip>85221</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>1307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus</name>
      <address>
        <city>Frankfurt</city>
        <zip>60431</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Frankfurt/ Medizinische Klinik 1</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH</name>
      <address>
        <city>Halle</city>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K.</name>
      <address>
        <city>Hamburg</city>
        <zip>20251</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterologie Opernstrasse</name>
      <address>
        <city>Kassel</city>
        <zip>34117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Schleswig-Holstein - Kiel</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Staedtisches Klinikum Lueneburg</name>
      <address>
        <city>Lueneburg</city>
        <zip>21339</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Otto-von-Guericke-Universität Magdeburg</name>
      <address>
        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Fakultät Mannheim der Universität Heidelberg</name>
      <address>
        <city>Mannheim</city>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterologische Gemeinschaftspraxis Minden</name>
      <address>
        <city>Minden</city>
        <zip>32423</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universitaet Muenchen</name>
      <address>
        <city>Muenchen</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Ulf Helwig</name>
      <address>
        <city>Oldenburg</city>
        <zip>26123</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentrum für Gastroenterologie Saar MVZ GmbH</name>
      <address>
        <city>Saarbrücken</city>
        <zip>66111</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinik Tuebingen</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Ulm, Klinik fuer Innere Medizin II</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Villa Sofia-Cervello</name>
      <address>
        <city>Palermo</city>
        <zip>90146</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera G.Salvini Ospedale di Rho</name>
      <address>
        <city>RHO</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Gemelli Università Cattolica</name>
      <address>
        <city>Roma</city>
        <zip>168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AO Ordine Mauriziano</name>
      <address>
        <city>Torino</city>
        <zip>10128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Haeundae Paik Hospital</name>
      <address>
        <city>Busan</city>
        <zip>48108</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KyungHee University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>102-1703</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onze Lieve Vrouwe Gasthuis</name>
      <address>
        <city>Amsterdam</city>
        <zip>1091 AC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht Universitair Medisch Centrum</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboudumc</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sint Franciscus Gasthuis</name>
      <address>
        <city>Rotterdam</city>
        <zip>3045 PM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irkutsk State Medical Academy of Postgraduate Education</name>
      <address>
        <city>Irkutsk</city>
        <zip>664079</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olla-Med, Llc</name>
      <address>
        <city>Moscow</city>
        <zip>105554</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital #31</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GBUZ Respublican Clinical Hospital n.a. GG Kuvatova</name>
      <address>
        <city>Ufa</city>
        <zip>450005</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Fundacion Alcorcon</name>
      <address>
        <city>Alcorcón</city>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Arquitecto Marcide</name>
      <address>
        <city>Ferrol</city>
        <zip>15405</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Gral. Univ. Gregorio Maranon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Virgen de La Arrixaca</name>
      <address>
        <city>Murcia</city>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Virgen de La Victoria</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. de Navarra</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Montecelo</name>
      <address>
        <city>Pontevedra</city>
        <zip>36071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corporacio Sanitari Parc Tauli</name>
      <address>
        <city>Sabadell</city>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Clinico Univ. de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Marques de Valdecilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Clinico Univ. de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Alvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <zip>36213</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Clinico Univ. Lozano Blesa</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastromottagningen</name>
      <address>
        <city>Malmö</city>
        <zip>20502</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastromottagningen</name>
      <address>
        <city>Stockholm</city>
        <zip>18288</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pennine Acute Hospitals-Fairfield General Hospital</name>
      <address>
        <city>Bury</city>
        <zip>BL9 7TD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gloucestershire Hospitals NHS Foundation Trust - Cheltenham</name>
      <address>
        <city>Cheltenham</city>
        <zip>GL53 7AN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Devon &amp; Exeter Hospital</name>
      <address>
        <city>Exeter</city>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's Hospital</name>
      <address>
        <city>London</city>
        <zip>SW17 OQT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southampton University Hospitals NHS Trust</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <results_first_submitted>August 16, 2023</results_first_submitted>
  <results_first_submitted_qc>August 16, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">September 13, 2023</results_first_posted>
  <last_update_submitted>August 16, 2023</last_update_submitted>
  <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ustekinumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson &amp; Johnson is available at www.janssen.com/clinical-trials\transparency.&#xD;
As noted on this site, requests for access to the study data can be submitted through Yale open and Access (YODA) Project site at yoda.yale.edu</ipd_description>
    <ipd_url>https://www.janssen.com/clinical-trials/transparency</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>August 5, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03782376/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 17, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03782376/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group 1: Ustekinumab (IV Re-induction)</title>
          <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
        </group>
        <group group_id="P2">
          <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
          <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1: Ustekinumab (IV Re-induction)</title>
          <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
        </group>
        <group group_id="B2">
          <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
          <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</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="108"/>
            <count group_id="B2" value="107"/>
            <count group_id="B3" value="215"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.8" spread="13.63"/>
                    <measurement group_id="B2" value="40" spread="13.07"/>
                    <measurement group_id="B3" value="40.9" spread="13.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="206"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="17"/>
                  </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="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="179"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Czech Republic</title>
              <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>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <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>Netherlands</title>
              <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>Republic of Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <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>Sweden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <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>United States of America</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Clinical Response at Week 16</title>
        <description>Clinical response was defined as greater than or equal to (&gt;=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score &lt; 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.</description>
        <time_frame>Week 16</time_frame>
        <population>Full analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Ustekinumab (IV Re-induction)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Response at Week 16</title>
          <description>Clinical response was defined as greater than or equal to (&gt;=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score &lt; 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.</description>
          <population>Full analysis set included all randomized participants.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.1"/>
                    <measurement group_id="O2" value="37.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Clinical Remission at Weeks 8, 16, and 24</title>
        <description>Percentage of participants with clinical remission at Weeks 8, 16, and 24 were reported. Clinical remission was defined as CDAI score of &lt;150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score.</description>
        <time_frame>Weeks 8, 16, and 24</time_frame>
        <population>Full analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Ustekinumab (IV Re-induction)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Remission at Weeks 8, 16, and 24</title>
          <description>Percentage of participants with clinical remission at Weeks 8, 16, and 24 were reported. Clinical remission was defined as CDAI score of &lt;150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score.</description>
          <population>Full analysis set included all randomized participants.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.2"/>
                    <measurement group_id="O2" value="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.0"/>
                    <measurement group_id="O2" value="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Clinical Response at Weeks 8 and 24</title>
        <description>Clinical response was defined as a &gt;=100-point reduction from the baseline in CDAI score or a CDAI score &lt;150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.</description>
        <time_frame>Weeks 8 and 24</time_frame>
        <population>Full analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Ustekinumab (IV Re-induction)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Response at Weeks 8 and 24</title>
          <description>Clinical response was defined as a &gt;=100-point reduction from the baseline in CDAI score or a CDAI score &lt;150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.</description>
          <population>Full analysis set included all randomized participants.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.9"/>
                    <measurement group_id="O2" value="44.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.2"/>
                    <measurement group_id="O2" value="39.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Weeks 16 and 24</title>
        <description>Percentage of participants with normalization at Weeks 16 and 24, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (&lt;=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as &lt;=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward.</description>
        <time_frame>Weeks 16 and 24</time_frame>
        <population>Full analysis set included all randomized participants with either elevated CRP and/or elevated fCal at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Ustekinumab (IV Re-induction)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Weeks 16 and 24</title>
          <description>Percentage of participants with normalization at Weeks 16 and 24, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (&lt;=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as &lt;=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward.</description>
          <population>Full analysis set included all randomized participants with either elevated CRP and/or elevated fCal at baseline.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.9"/>
                    <measurement group_id="O2" value="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
        <description>An adverse event was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. TEAEs were adverse events with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. In this outcome measure, TEAEs including all AEs irrespective of being serious or non-serious AE are reported.</description>
        <time_frame>From baseline (Week 0) up to Week 36</time_frame>
        <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Ustekinumab (IV Re-induction)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
          <description>An adverse event was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. TEAEs were adverse events with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. In this outcome measure, TEAEs including all AEs irrespective of being serious or non-serious AE are reported.</description>
          <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.4"/>
                    <measurement group_id="O2" value="72.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)</title>
        <description>A serious adverse event (SAE) was an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; a suspected transmission of any infectious agent via a medicinal product; medically important. TESAEs were adverse events with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.</description>
        <time_frame>From baseline (Week 0) up to Week 36</time_frame>
        <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Ustekinumab (IV Re-induction)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)</title>
          <description>A serious adverse event (SAE) was an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; a suspected transmission of any infectious agent via a medicinal product; medically important. TESAEs were adverse events with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.</description>
          <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                    <measurement group_id="O2" value="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Treatment-emergent Infections</title>
        <description>Percentage of participants with treatment-emergent infections were reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.</description>
        <time_frame>From baseline (Week 0) up to Week 36</time_frame>
        <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Ustekinumab (IV Re-induction)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment-emergent Infections</title>
          <description>Percentage of participants with treatment-emergent infections were reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.</description>
          <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="29.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Treatment-emergent Serious Infections</title>
        <description>Percentage of participants with treatment-emergent serious infections was reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.</description>
        <time_frame>From baseline (Week 0) up to Week 36</time_frame>
        <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Ustekinumab (IV Re-induction)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment-emergent Serious Infections</title>
          <description>Percentage of participants with treatment-emergent serious infections was reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.</description>
          <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9"/>
                    <measurement group_id="O2" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein)</title>
        <description>Change from baseline in clinical laboratory values for hematology (hemoglobin) and chemistry (albumin, total protein) was reported.</description>
        <time_frame>Baseline, Weeks 8, 16, 24</time_frame>
        <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Ustekinumab (IV Re-induction)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein)</title>
          <description>Change from baseline in clinical laboratory values for hematology (hemoglobin) and chemistry (albumin, total protein) was reported.</description>
          <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.</population>
          <units>Grams per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8: Hematology (Hemoglobin)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.893" spread="9.5568"/>
                    <measurement group_id="O2" value="-0.185" spread="7.8669"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Hematology (Hemoglobin)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.245" spread="10.4621"/>
                    <measurement group_id="O2" value="0.835" spread="10.4652"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Hematology (Hemoglobin)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.203" spread="11.2408"/>
                    <measurement group_id="O2" value="-0.400" spread="11.2610"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Chemistry (Albumin)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.765" spread="2.9456"/>
                    <measurement group_id="O2" value="0.286" spread="2.6671"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Chemistry (Albumin)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.567" spread="3.0649"/>
                    <measurement group_id="O2" value="0.554" spread="3.3753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Chemistry (Albumin)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.741" spread="2.9613"/>
                    <measurement group_id="O2" value="0.221" spread="3.1690"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Chemistry (Total protein)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.588" spread="4.6806"/>
                    <measurement group_id="O2" value="0.265" spread="4.3803"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Chemistry (Total protein)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.340" spread="5.2418"/>
                    <measurement group_id="O2" value="0.783" spread="4.7690"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Chemistry (Total protein)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.605" spread="4.4150"/>
                    <measurement group_id="O2" value="0.333" spread="5.4954"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit)</title>
        <description>Change from baseline in clinical laboratory values for hematology (hematocrit) was reported.</description>
        <time_frame>Baseline, Weeks 8, 16, 24</time_frame>
        <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Ustekinumab (IV Re-induction)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit)</title>
          <description>Change from baseline in clinical laboratory values for hematology (hematocrit) was reported.</description>
          <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.</population>
          <units>Percentage of red blood cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.009" spread="0.0313"/>
                    <measurement group_id="O2" value="-0.001" spread="0.277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.010" spread="0.0306"/>
                    <measurement group_id="O2" value="0.001" spread="0.0356"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.009" spread="0.0358"/>
                    <measurement group_id="O2" value="0.001" spread="0.0349"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets)</title>
        <description>Change from baseline in clinical laboratory values for hematology (total WBC, neutrophils, absolute lymphocyte, eosinophils, platelets) was reported.</description>
        <time_frame>Baseline, Weeks 8, 16, 24</time_frame>
        <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specific parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Ustekinumab (IV Re-induction)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets)</title>
          <description>Change from baseline in clinical laboratory values for hematology (total WBC, neutrophils, absolute lymphocyte, eosinophils, platelets) was reported.</description>
          <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specific parameters.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8: Total WBC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.386" spread="1.8358"/>
                    <measurement group_id="O2" value="-0.272" spread="1.7301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Total WBC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.329" spread="2.2700"/>
                    <measurement group_id="O2" value="-0.124" spread="2.1404"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Total WBC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.149" spread="2.2347"/>
                    <measurement group_id="O2" value="0.104" spread="1.6612"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8:Neutrophils</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.235" spread="1.7610"/>
                    <measurement group_id="O2" value="-0.241" spread="1.6154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Neutrophils</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.195" spread="2.0172"/>
                    <measurement group_id="O2" value="-0.053" spread="2.1811"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Neutrophils</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.038" spread="2.2944"/>
                    <measurement group_id="O2" value="0.133" spread="1.4312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Absolute Lymphocytes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.101" spread="0.4962"/>
                    <measurement group_id="O2" value="-0.020" spread="0.3415"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Absolute Lymphocytes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.088" spread="0.5690"/>
                    <measurement group_id="O2" value="-0.052" spread="0.3997"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Absolute Lymphocytes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.088" spread="0.6599"/>
                    <measurement group_id="O2" value="-0.021" spread="0.3960"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Eosinophils</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.009" spread="0.0876"/>
                    <measurement group_id="O2" value="-0.004" spread="0.1153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Eosinophils</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.014" spread="0.1176"/>
                    <measurement group_id="O2" value="-0.013" spread="0.1330"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Eosinophils</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.001" spread="0.0912"/>
                    <measurement group_id="O2" value="-0.008" spread="0.1136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Platelets</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.65" spread="56.553"/>
                    <measurement group_id="O2" value="-0.67" spread="51.591"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Platelets</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.28" spread="60.105"/>
                    <measurement group_id="O2" value="4.53" spread="60.785"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Platelets</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.89" spread="62.671"/>
                    <measurement group_id="O2" value="-0.53" spread="56.624"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST])</title>
        <description>Change from baseline in clinical laboratory values for chemistry (alkaline, ALT, AST) was reported.</description>
        <time_frame>Baseline, Weeks 8, 16, 24</time_frame>
        <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Ustekinumab (IV Re-induction)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST])</title>
          <description>Change from baseline in clinical laboratory values for chemistry (alkaline, ALT, AST) was reported.</description>
          <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.</population>
          <units>Units per Liter (U/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8: Alkaline Phosphatase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.343" spread="10.7404"/>
                    <measurement group_id="O2" value="-0.582" spread="10.3565"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Alkaline Phosphatase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.072" spread="12.9488"/>
                    <measurement group_id="O2" value="0.923" spread="11.5154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Alkaline Phosphatase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.296" spread="14.2649"/>
                    <measurement group_id="O2" value="0.078" spread="16.1594"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: ALT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.347" spread="9.3642"/>
                    <measurement group_id="O2" value="-0.412" spread="7.9001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: ALT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.811" spread="8.3898"/>
                    <measurement group_id="O2" value="-0.101" spread="9.9750"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: ALT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.463" spread="10.1470"/>
                    <measurement group_id="O2" value="2.224" spread="15.5979"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: AST</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.525" spread="12.0147"/>
                    <measurement group_id="O2" value="0.144" spread="4.8584"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: AST</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.208" spread="12.6366"/>
                    <measurement group_id="O2" value="0.163" spread="5.4557"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: AST</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.741" spread="5.6718"/>
                    <measurement group_id="O2" value="1.519" spread="7.3047"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine)</title>
        <description>Change from baseline in clinical laboratory values for chemistry (total bilirubin, direct bilirubin, creatinine) was reported.</description>
        <time_frame>Baseline, Weeks 8, 16, 24</time_frame>
        <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Ustekinumab (IV Re-induction)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine)</title>
          <description>Change from baseline in clinical laboratory values for chemistry (total bilirubin, direct bilirubin, creatinine) was reported.</description>
          <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.</population>
          <units>micromole per liter (mcmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8: Total Bilirubin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.639" spread="2.5303"/>
                    <measurement group_id="O2" value="-0.131" spread="2.9617"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Total Bilirubin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.476" spread="3.4135"/>
                    <measurement group_id="O2" value="0.555" spread="3.6679"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Total Bilirubin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.687" spread="3.0396"/>
                    <measurement group_id="O2" value="0.254" spread="3.1664"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Direct Bilirubin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.086" spread="0.5495"/>
                    <measurement group_id="O2" value="-0.010" spread="0.5998"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Direct Bilirubin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.154" spread="0.6910"/>
                    <measurement group_id="O2" value="0.071" spread="0.7628"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Direct Bilirubin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.109" spread="0.5393"/>
                    <measurement group_id="O2" value="0.009" spread="0.7612"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Creatinine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.446" spread="8.9118"/>
                    <measurement group_id="O2" value="-0.308" spread="9.6489"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16: Creatinine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.624" spread="9.7987"/>
                    <measurement group_id="O2" value="1.117" spread="9.0316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24: Creatinine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.717" spread="9.5267"/>
                    <measurement group_id="O2" value="0.336" spread="8.4020"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate)</title>
        <description>Change from baseline in clinical laboratory values for chemistry (sodium, potassium, chloride, BUN/urea, calcium, phosphate) was reported.</description>
        <time_frame>Baseline, Weeks 8, 16, 24</time_frame>
        <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Ustekinumab (IV Re-induction)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
            <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate)</title>
          <description>Change from baseline in clinical laboratory values for chemistry (sodium, potassium, chloride, BUN/urea, calcium, phosphate) was reported.</description>
          <population>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.</population>
          <units>millimoles per liter (mmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sodium: Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.108" spread="2.5714"/>
                    <measurement group_id="O2" value="-0.061" spread="2.2375"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.165" spread="2.2299"/>
                    <measurement group_id="O2" value="0.011" spread="2.3370"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.235" spread="2.2928"/>
                    <measurement group_id="O2" value="-0.117" spread="2.0454"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.126" spread="0.3596"/>
                    <measurement group_id="O2" value="0.050" spread="0.3269"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.105" spread="0.3745"/>
                    <measurement group_id="O2" value="-0.002" spread="0.3933"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium: Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.067" spread="0.3732"/>
                    <measurement group_id="O2" value="0.001" spread="0.3185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride: Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.078" spread="2.9136"/>
                    <measurement group_id="O2" value="-0.520" spread="2.4714"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride: Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.299" spread="2.4798"/>
                    <measurement group_id="O2" value="-0.489" spread="2.5398"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride: Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.160" spread="2.4107"/>
                    <measurement group_id="O2" value="-0.481" spread="2.2160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BUN/urea: Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.279" spread="1.0050"/>
                    <measurement group_id="O2" value="0.248" spread="1.0710"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BUN/urea: Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.204" spread="1.2812"/>
                    <measurement group_id="O2" value="0.029" spread="1.2841"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BUN/urea: Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.304" spread="1.2031"/>
                    <measurement group_id="O2" value="0.179" spread="1.0629"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium: Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.022" spread="0.0967"/>
                    <measurement group_id="O2" value="0.013" spread="0.0968"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium: Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.007" spread="0.1010"/>
                    <measurement group_id="O2" value="0.007" spread="0.1098"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium: Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.008" spread="0.1101"/>
                    <measurement group_id="O2" value="0.004" spread="0.1109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate: Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.005" spread="0.2015"/>
                    <measurement group_id="O2" value="0.046" spread="0.2024"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate: Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.006" spread="0.1946"/>
                    <measurement group_id="O2" value="0.026" spread="0.1905"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate: Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.018" spread="0.1612"/>
                    <measurement group_id="O2" value="0.021" spread="0.1938"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline (Week 0) up to Week 36</time_frame>
      <desc>Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1: Ustekinumab (IV Re-induction)</title>
          <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) injection and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
        </group>
        <group group_id="E2">
          <title>Group 2: Ustekinumab (Continuous q8w SC Maintenance)</title>
          <description>Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 23.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Crohn's Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Ileal Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Small Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Small Intestinal Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Anal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Tooth Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes Mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Malignant Melanoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion Spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus Urinary</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Renal Atrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Urethral Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA Version 23.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="73" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="77" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Iron Deficiency Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye Irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Abdominal Mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Abdominal Tenderness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Anal Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Anal Fissure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Anal Fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Anal Skin Tags</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Crohn's Disease</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Eosinophilic Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Food Poisoning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal Reflux Disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Large Intestine Polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Rectal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Subileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Influenza Like Illness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Injection Site Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Injection Site Mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal Allergy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess Soft Tissue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Anal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Clostridium Difficile Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Coronavirus Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Enteritis Infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Erythema Migrans</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Gastroenteritis Viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Infected Fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Otitis Externa</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Pharyngitis Streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Pyelitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Ureaplasma Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Foot Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Infusion Related Reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Injection Related Reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Ligament Rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Procedural Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Skin Laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Spinal Compression Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Tendon Rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Thermal Burn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Vaccination Complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Blood Alkaline Phosphatase Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Blood Creatinine Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Blood Magnesium Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>C-Reactive Protein Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Gamma-Glutamyltransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Sars-Cov-2 Test Positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Vitamin D Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Weight Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Iron Deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Type 2 Diabetes Mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Vitamin D Deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Zinc Deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Greater Trochanteric Pain Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Groin Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Muscle Contracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Pain in Jaw</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Polyarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Rheumatic Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Spondylitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Pituitary Tumour Benign</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid Arteriosclerosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Dizziness Postural</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Ophthalmic Migraine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Affective Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Conversion Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvi-Ureteric Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cystocele</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Female Genital Tract Fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Heavy Menstrual Bleeding</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Pelvic Fluid Collection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Scrotal Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Dyspnoea Exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Productive Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Rhinitis Allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Tonsillar Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Decubitus Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Dermal Cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Erythema Nodosum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Superficial Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </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>If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Director GI Clinical Development</name_or_title>
      <organization>Janssen-Cilag Ltd.</organization>
      <phone>844-434-4210</phone>
      <email>ClinicalTrialDisclosure@its.jnj.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/NCT03782376
org study id: CR108533
secondary id: 2018-002629-51
secondary id: CNTO1275CRD3008
nct id: NCT03782376
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary purpose of this study is to evaluate the efficacy and safety of a single
      intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg)
      ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every
      8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.
This study compares the efficacy and safety of a single weight-tiered based IV re-induction
      dose of approximately 6 mg/kg ustekinumab versus continuing with regular SC q8w 90 mg
      ustekinumab administration. It consists of screening (5 weeks); treatment period (Week 0 to
      24); and safety follow up visit (20 weeks after last dose). The primary hypothesis is that a
      single IV re-induction dose of ustekinumab is superior to continuing with regular SC q8w
      maintenance treatment as measured by clinical response after 16 weeks of treatment. Study
      assessments will include Crohn's disease activity index (CDAI), video ileocolonoscopy,
      patient-reported outcomes (PROs), laboratory evaluations, biomarkers, review of concomitant
      medications and adverse events (AEs), and evaluation of serum concentrations of study agent
      as well as development of antibodies to study agent. All participants will be randomly
      assigned to receive either ustekinumab IV re-induction or regular SC q8w 90 mg ustekinumab
      injection at baseline in a double dummy design. No participants will be treated with placebo
      only.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants With Clinical Response at Week 16
time frame: Week 16
description: Clinical response was defined as greater than or equal to (>=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score < 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.
measure: Percentage of Participants With Clinical Remission at Weeks 8, 16, and 24
time frame: Weeks 8, 16, and 24
description: Percentage of participants with clinical remission at Weeks 8, 16, and 24 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score.
measure: Percentage of Participants With Clinical Response at Weeks 8 and 24
time frame: Weeks 8 and 24
description: Clinical response was defined as a >=100-point reduction from the baseline in CDAI score or a CDAI score <150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.
measure: Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Weeks 16 and 24
time frame: Weeks 16 and 24
description: Percentage of participants with normalization at Weeks 16 and 24, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (<=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as <=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward.
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
time frame: From baseline (Week 0) up to Week 36
description: An adverse event was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. TEAEs were adverse events with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. In this outcome measure, TEAEs including all AEs irrespective of being serious or non-serious AE are reported.
measure: Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
time frame: From baseline (Week 0) up to Week 36
description: A serious adverse event (SAE) was an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; a suspected transmission of any infectious agent via a medicinal product; medically important. TESAEs were adverse events with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.
measure: Percentage of Participants With Treatment-emergent Infections
time frame: From baseline (Week 0) up to Week 36
description: Percentage of participants with treatment-emergent infections were reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.
measure: Percentage of Participants With Treatment-emergent Serious Infections
time frame: From baseline (Week 0) up to Week 36
description: Percentage of participants with treatment-emergent serious infections was reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.
measure: Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein)
time frame: Baseline, Weeks 8, 16, 24
description: Change from baseline in clinical laboratory values for hematology (hemoglobin) and chemistry (albumin, total protein) was reported.
measure: Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit)
time frame: Baseline, Weeks 8, 16, 24
description: Change from baseline in clinical laboratory values for hematology (hematocrit) was reported.
measure: Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets)
time frame: Baseline, Weeks 8, 16, 24
description: Change from baseline in clinical laboratory values for hematology (total WBC, neutrophils, absolute lymphocyte, eosinophils, platelets) was reported.
measure: Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST])
time frame: Baseline, Weeks 8, 16, 24
description: Change from baseline in clinical laboratory values for chemistry (alkaline, ALT, AST) was reported.
measure: Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine)
time frame: Baseline, Weeks 8, 16, 24
description: Change from baseline in clinical laboratory values for chemistry (total bilirubin, direct bilirubin, creatinine) was reported.
measure: Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate)
time frame: Baseline, Weeks 8, 16, 24
description: Change from baseline in clinical laboratory values for chemistry (sodium, potassium, chloride, BUN/urea, calcium, phosphate) was reported.
arm group label: Group 1: Ustekinumab (IV re-induction)
arm group type: Experimental
description: Participants who experience a secondary loss of response (LoR) to 90 mg ustekinumab maintenance treatment, administered subcutaneously every 8 weeks (q8w) will receive a weight-tiered based ustekinumab IV re-induction dose of approximately 6 mg/kg and matching placebo subcutaneously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.
arm group label: Group 2: Ustekinumab (Continuous q8w SC maintenance)
arm group type: Active Comparator
description: Participants who experience a secondary LoR to 90 mg ustekinumab maintenance treatment, administered subcutaneously q8w will receive ustekinumab 90 mg subcutaneously and matching placebo intravenously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.
intervention type: Drug
intervention name: Ustekinumab approximately 6 mg/kg (IV)
description: Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0.
arm group label: Group 1: Ustekinumab (IV re-induction)
other name: STELARA
intervention type: Drug
intervention name: Placebo (SC)
description: Participants will receive SC injection of placebo at Week 0.
arm group label: Group 1: Ustekinumab (IV re-induction)
intervention type: Drug
intervention name: Placebo (IV)
description: Participants will receive IV infusion of placebo at Week 0.
arm group label: Group 2: Ustekinumab (Continuous q8w SC maintenance)
intervention type: Drug
intervention name: Ustekinumab 90 mg (SC) Group 1
description: Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16.
arm group label: Group 1: Ustekinumab (IV re-induction)
other name: STELARA
intervention type: Drug
intervention name: Ustekinumab 90 mg (SC) Group 2
description: Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16.
arm group label: Group 2: Ustekinumab (Continuous q8w SC maintenance)
other name: STELARA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen-Cilag Ltd. Clinical Trial
role: Study Director
affiliation: Janssen-Cilag Ltd.
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country: Austria
country: Czechia
country: France
country: Germany
country: Italy
country: Korea, Republic of
country: Netherlands
country: Russian Federation
country: Spain
country: Sweden
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Ustekinumab
sharing ipd: Yes
ipd description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency.
As noted on this site, requests for access to the study data can be submitted through Yale open and Access (YODA) Project site at yoda.yale.edu
ipd url: https://www.janssen.com/clinical-trials/transparency
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 