<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/NCT03234907</url>
  </required_header>
  <id_info>
    <org_study_id>Vedolizumab-3034</org_study_id>
    <secondary_id>U1111-1195-3932</secondary_id>
    <nct_id>NCT03234907</nct_id>
  </id_info>
  <brief_title>Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease.</brief_title>
  <official_title>A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and efficacy of vedolizumab intravenous&#xD;
      (IV) infusion as induction treatment in Chinese participants with moderately to severely&#xD;
      active Crohn's disease (CD) at Week 10.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called vedolizumab. Vedolizumab will be administered&#xD;
      as an intravenous (IV) infusion in Chinese participants. This study will investigate the&#xD;
      efficacy and safety of vedolizumab IV as induction and maintenance therapy in participants&#xD;
      with moderately to severely active Crohn's Disease (CD).&#xD;
&#xD;
      The study will enroll approximately 300 moderately to severely active Chinese patients with&#xD;
      CD.&#xD;
&#xD;
      Induction Phase: participants will be randomized 2:1 to receive:&#xD;
&#xD;
        -  Vedolizumab IV 300 mg&#xD;
&#xD;
        -  Placebo IV&#xD;
&#xD;
      Participants will receive vedolizumab 300 mg or matching placebo, intravenous (IV) infusion&#xD;
      at Weeks 0, 2, and 6 in the induction phase. At Week 10, participants will be assessed for&#xD;
      clinical response. Results of Week 10 clinical response will determine the treatment pathway&#xD;
      in the maintenance phase.&#xD;
&#xD;
      Maintenance Phase: participants who achieved clinical response at Week 10 will continue to&#xD;
      receive the same treatment as they received in Induction Phase; every 8 weeks (Q8W) starting&#xD;
      at Week 14. Participants who received vedolizumab IV or placebo in the Induction Phase and&#xD;
      did not achieve clinical response at Week 10 will receive vedolizumab every 4 weeks (Q4W)&#xD;
      starting at Week 14.&#xD;
&#xD;
      This multi-center trial will be conducted in China. The overall time to participate in this&#xD;
      study is 60 weeks. Participants will make multiple visits to the clinic, and will be&#xD;
      contacted by telephone, 6 months after last dose of study drug for a long-term follow-up&#xD;
      safety survey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2017</start_date>
  <completion_date type="Actual">August 14, 2020</completion_date>
  <primary_completion_date type="Actual">August 14, 2020</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 Enhanced Clinical Response in the Induction Phase at Week 10</measure>
    <time_frame>Week 10</time_frame>
    <description>Enhanced clinical response was defined as ≥100-point decrease from Baseline in the Crohn's Disease Activity Index (CDAI) score at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Clinical Remission in the Induction Phase at Week 10</measure>
    <time_frame>Week 10</time_frame>
    <description>Clinical remission was defined as CDAI score of ≤150 points at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">215</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Induction Phase: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Induction Phase: Vedolizumab 300 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maintenance Phase: Induction Placebo to Placebo Q4W</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants who received placebo in the Induction Phase and achieved clinical response at Week 10 continued to receive placebo in the Maintenance Phase. Vedolizumab placebo-matching, IV infusion, once every 4 weeks (Q4W), from Week 14 to Week 58.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maintenance Phase: Induction Placebo to Vedolizumab 300 mg Q4W</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received placebo in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q8W</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received vedolizumab in the Induction Phase and achieved clinical response at Week 10 continued to receive vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W), at Weeks 14, 22, 30, 38, 46 and 54 and vedolizumab placebo-matching, IV infusion, Q8W, at Weeks 18, 26, 34, 42, 50 and 58 to maintain double-blind.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q4W</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received vedolizumab in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vedolizumab IV</intervention_name>
    <description>Vedolizumab IV infusion</description>
    <arm_group_label>Induction Phase: Placebo</arm_group_label>
    <arm_group_label>Maintenance Phase: Induction Placebo to Placebo Q4W</arm_group_label>
    <arm_group_label>Maintenance Phase: Induction Placebo to Vedolizumab 300 mg Q4W</arm_group_label>
    <arm_group_label>Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q4W</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Vedolizumab placebo-matching</description>
    <arm_group_label>Induction Phase: Vedolizumab 300 mg</arm_group_label>
    <arm_group_label>Maintenance Phase: Induction Placebo to Placebo Q4W</arm_group_label>
    <arm_group_label>Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q8W</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Has a diagnosis of Crohn's disease (CD) established at least 3 months prior to&#xD;
             Screening by clinical and endoscopic evidence corroborated by a histopathology report.&#xD;
             Cases of CD established at least 6 months prior to randomization for which a&#xD;
             histopathology report is not available will be considered based on the weight of&#xD;
             evidence supporting the diagnosis and excluding other potential diagnosis, and must be&#xD;
             discussed with the sponsor on a case-by-case basis prior to randomization.&#xD;
&#xD;
          2. Has moderately to severely active CD as determined by a Crohn's Disease Activity Index&#xD;
             (CDAI) score of 220 to 400 within 7 days prior to the first dose of study drug and 1&#xD;
             of the following:&#xD;
&#xD;
               -  C-reactive protein (CRP) level &gt;2.87 mg/L during the Screening Phase, OR&#xD;
&#xD;
               -  Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic&#xD;
                  ulcerations (each &gt;0.5 cm in diameter) or 10 aphtous ulcerations (involving a&#xD;
                  minimum of 10 contiguous cm of intestine) consistent with CD, within 4 months&#xD;
                  prior to randomization, OR&#xD;
&#xD;
               -  Fecal calprotectin &gt;250 μg/g stool during the Screening Phase in conjunction with&#xD;
                  computed tomography enterography (CTE), magnetic resonance enterography (MRE),&#xD;
                  contrast enhanced small bowel radiography, or wireless capsule endoscopy&#xD;
                  revealing CD ulcerations (aphthae not sufficient), within 4 months prior to&#xD;
                  Screening&#xD;
&#xD;
          3. Has CD involvement of the ileum and/or colon, at a minimum.&#xD;
&#xD;
          4. Has extensive colitis or pancolitis of &gt;8 years duration or limited colitis of &gt;12&#xD;
             years duration must have documented evidence that a surveillance colonoscopy was&#xD;
             performed within 12 months prior to initial screening (may be performed during&#xD;
             Screening if not performed in previous 12 months).&#xD;
&#xD;
          5. Has a family history of colorectal cancer, personal history of increased colorectal&#xD;
             cancer risk, age &gt;50 years, or other known risk factor must be up-to-date on&#xD;
             colorectal cancer surveillance (may be performed during Screening).&#xD;
&#xD;
          6. Has demonstrated an inadequate response to, loss of response to, or intolerance of at&#xD;
             least 1 of the following agents as defined below:&#xD;
&#xD;
               -  Corticosteroids.&#xD;
&#xD;
               -  Immunomodulators.&#xD;
&#xD;
               -  Tumor necrosis factor-alpha (TNF-α) antagonists.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has evidence of abdominal abscess at the initial Screening Visit.&#xD;
&#xD;
          2. Has had extensive colonic resection, subtotal or total colectomy.&#xD;
&#xD;
          3. Has a history of &gt;3 small bowel resections or diagnosis of short bowel syndrome.&#xD;
&#xD;
          4. Has had ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, or&#xD;
             evidence of fixed stenosis, or small bowel stenosis with prestenotic dilation.&#xD;
&#xD;
          5. Has had previous exposure to approved or investigational anti-integrins (e.g.,&#xD;
             natalizumab, efalizumab, etrolizumab, or AMG-181), or MAdCAM-1 antagonists, or&#xD;
             rituximab.&#xD;
&#xD;
          6. Has used topical (rectal) treatment with 5-ASA, corticosteroid enemas/suppositories or&#xD;
             traditional Chinese medications for CD treatment within 2 weeks of the administration&#xD;
             of the first dose of study drug.&#xD;
&#xD;
          7. Requires currently or is anticipated to require surgical intervention for CD during&#xD;
             the study.&#xD;
&#xD;
          8. Has a history or evidence of adenomatous colonic polyps that have not been removed.&#xD;
&#xD;
          9. Has a history or evidence of colonic mucosal dysplasia including low or high-grade&#xD;
             dysplasia, as well as indeterminate for dysplasia.&#xD;
&#xD;
         10. Has a suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis,&#xD;
             ischemic colitis, and radiation colitis.&#xD;
&#xD;
         11. Has evidence of treatment for C.difficile infection or other intestinal pathogen with&#xD;
             28 days prior to first dose of study drug.&#xD;
&#xD;
         12. Has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV)&#xD;
             infection.&#xD;
&#xD;
         13. Has active or latent tuberculosis.&#xD;
&#xD;
         14. Has any identified congenital or acquired immunodeficiency (e.g., common variable&#xD;
             immunodeficiency, human immunodeficiency virus [HIV] infection, organ&#xD;
             transplantation).&#xD;
&#xD;
         15. Has any history of malignancy, except for the following: (a) adequately-treated&#xD;
             nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been&#xD;
             adequately treated and that has not recurred for at least 1 year prior to&#xD;
             randomization; and (c) history of cervical carcinoma in situ that has been adequately&#xD;
             treated and that has not recurred for at least 3 years prior to randomization.&#xD;
             Participants with remote history of malignancy (e.g., &gt;10 years since completion of&#xD;
             curative therapy without recurrence) will be considered based on the nature of the&#xD;
             malignancy and the therapy received and must be discussed with the sponsor on a&#xD;
             case-by-case basis prior to randomization.&#xD;
&#xD;
         16. Has a history of any major neurological disorders, including stroke, multiple&#xD;
             sclerosis, brain tumor, or neurodegenerative disease.&#xD;
&#xD;
         17. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom&#xD;
             checklist at Screening or prior to the administration of the first dose of study drug&#xD;
             at Week 0.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director Clinical Science</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230024</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510655</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Wuxi</city>
        <state>Jiangsu</state>
        <zip>241023</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5f6b603b4db2bf003ab4a32b?idFilter=%5B%22Vedolizumab-3034%22%5D</url>
    <description>To obtain more information on the study, click on this link.</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <results_first_submitted>August 24, 2022</results_first_submitted>
  <results_first_submitted_qc>August 24, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 21, 2022</results_first_posted>
  <disposition_first_submitted>July 27, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>July 27, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 2, 2021</disposition_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug therapy</keyword>
  <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>Vedolizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</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>April 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03234907/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 5, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03234907/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 27 investigative sites in China from 3 August 2017 to 14 August 2020.</recruitment_details>
      <pre_assignment_details>Participants with moderately to severely active Crohn's disease were enrolled and randomized in 2:1 ratio to receive vedolizumab 300 mg or placebo in the Induction Phase of the study. Participants who achieved clinical response at Week 10 entered Maintenance Phase and continued the same study drug, placebo for every 4 weeks and vedolizumab 300 mg for every 8 weeks up to Week 58. Participants who did not achieve response received vedolizumab 300 mg every 4 weeks up to Week 58.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Induction Phase: Placebo</title>
          <description>Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase.</description>
        </group>
        <group group_id="P2">
          <title>Induction Phase: Vedolizumab 300 mg</title>
          <description>Vedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase.</description>
        </group>
        <group group_id="P3">
          <title>Maintenance Phase: Induction Placebo to Placebo Q4W</title>
          <description>Participants who received placebo in the Induction Phase and achieved clinical response at Week 10 continued to receive placebo in the Maintenance Phase. Vedolizumab placebo-matching, IV infusion, once every 4 weeks (Q4W), from Week 14 to Week 58.</description>
        </group>
        <group group_id="P4">
          <title>Maintenance Phase: Induction Placebo to Vedolizumab 300 mg Q4W</title>
          <description>Participants who received placebo in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.</description>
        </group>
        <group group_id="P5">
          <title>Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q8W</title>
          <description>Participants who received vedolizumab in the Induction Phase and achieved clinical response at Week 10 continued to receive vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W), at Weeks 14, 22, 30, 38, 46 and 54 and vedolizumab placebo-matching, IV infusion, Q8W, at Weeks 18, 26, 34, 42, 50 and 58 to maintain double-blind.</description>
        </group>
        <group group_id="P6">
          <title>Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q4W</title>
          <description>Participants who received vedolizumab in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Induction Phase (Week 0 to Week 10)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="144"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="144"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="138"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Enrolled but not Treated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Maintenance Phase (Week 10 to Week 60)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="18"/>
                <participants group_id="P4" count="38"/>
                <participants group_id="P5" count="46"/>
                <participants group_id="P6" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="27"/>
                <participants group_id="P5" count="36"/>
                <participants group_id="P6" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="11"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason not Specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>FAS for the induction phase study included all randomized participants who received any amount of blinded study drug during the Induction Phase.</population>
      <group_list>
        <group group_id="B1">
          <title>Induction Phase: Placebo</title>
          <description>Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase.</description>
        </group>
        <group group_id="B2">
          <title>Induction Phase: Vedolizumab 300 mg</title>
          <description>Vedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase.</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="70"/>
            <count group_id="B2" value="144"/>
            <count group_id="B3" value="214"/>
          </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="31.1" spread="8.12"/>
                    <measurement group_id="B2" value="31.1" spread="10.10"/>
                    <measurement group_id="B3" value="31.1" spread="9.48"/>
                  </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="16"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="144"/>
                    <measurement group_id="B3" value="214"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="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="70"/>
                    <measurement group_id="B2" value="144"/>
                    <measurement group_id="B3" value="214"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</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>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.61" spread="10.662"/>
                    <measurement group_id="B2" value="54.33" spread="10.388"/>
                    <measurement group_id="B3" value="54.42" spread="10.454"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="168.18" spread="7.785"/>
                    <measurement group_id="B2" value="166.96" spread="8.064"/>
                    <measurement group_id="B3" value="167.36" spread="7.976"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>BMI = weight (kg)/[height (m)^2]</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.21" spread="2.978"/>
                    <measurement group_id="B2" value="19.38" spread="2.742"/>
                    <measurement group_id="B3" value="19.33" spread="2.815"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Enhanced Clinical Response in the Induction Phase at Week 10</title>
        <description>Enhanced clinical response was defined as ≥100-point decrease from Baseline in the Crohn's Disease Activity Index (CDAI) score at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.</description>
        <time_frame>Week 10</time_frame>
        <population>FAS for the induction phase study included all randomized participants who received any amount of blinded study drug during the Induction Phase.</population>
        <group_list>
          <group group_id="O1">
            <title>Induction Phase: Placebo</title>
            <description>Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase.</description>
          </group>
          <group group_id="O2">
            <title>Induction Phase: Vedolizumab 300 mg</title>
            <description>Vedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Enhanced Clinical Response in the Induction Phase at Week 10</title>
          <description>Enhanced clinical response was defined as ≥100-point decrease from Baseline in the Crohn's Disease Activity Index (CDAI) score at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.</description>
          <population>FAS for the induction phase study included all randomized participants who received any amount of blinded study drug during the Induction Phase.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.3" lower_limit="14.8" upper_limit="36.0"/>
                    <measurement group_id="O2" value="19.4" lower_limit="13.3" upper_limit="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.347</p_value>
            <p_value_desc>P-value was based on CHW test, based on weighted CMH chi-square test, with stratification according to: (1)previous failure of TNF-α antagonist therapy/concomitant use of immunomodulators(Yes/No);(2)concomitant use of oral corticosteroids(Yes/No).</p_value_desc>
            <method>Cui-Hung-Wang (CHW) test</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-5.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.2</ci_lower_limit>
            <ci_upper_limit>6.8</ci_upper_limit>
            <estimate_desc>Mantel-Haenszel estimate of the treatment difference and its variance was used to calculate the 95% confidence interval for the treatment difference. Adjustment to the stratification factors was implemented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Clinical Remission in the Induction Phase at Week 10</title>
        <description>Clinical remission was defined as CDAI score of ≤150 points at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity</description>
        <time_frame>Week 10</time_frame>
        <population>FAS for the induction phase study included all randomized participants who received any amount of blinded study drug during the Induction Phase.</population>
        <group_list>
          <group group_id="O1">
            <title>Induction Phase: Placebo</title>
            <description>Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase.</description>
          </group>
          <group group_id="O2">
            <title>Induction Phase: Vedolizumab 300 mg</title>
            <description>Vedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Remission in the Induction Phase at Week 10</title>
          <description>Clinical remission was defined as CDAI score of ≤150 points at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity</description>
          <population>FAS for the induction phase study included all randomized participants who received any amount of blinded study drug during the Induction Phase.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" lower_limit="5.1" upper_limit="21.3"/>
                    <measurement group_id="O2" value="9.0" lower_limit="4.9" upper_limit="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.531</p_value>
            <p_value_desc>P-value based on Cochran-Mantel-Haenszel, weighted CMH chi-square test, with stratification according to:(1)previous failure of TNF-α antagonist therapy/concomitant use of immunomodulators(Yes/No);(2)concomitant use of oral corticosteroids(Yes/No).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-2.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.5</ci_lower_limit>
            <ci_upper_limit>6.0</ci_upper_limit>
            <estimate_desc>Mantel-Haenszel estimate of the treatment difference and its variance was used to calculate the 95% confidence interval for the treatment difference. Adjustment to the stratification factors was implemented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of the study drug up to 18 weeks after the last dose (Induction Phase: Up to Week 28; Maintenance Phase: Up to Week 78)</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set for Induction Phase and Maintenance Phase included participants who received at least 1 dose of study drug in Induction and Maintenance Phase, respectively.</desc>
      <group_list>
        <group group_id="E1">
          <title>Induction Phase: Placebo</title>
          <description>Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase.</description>
        </group>
        <group group_id="E2">
          <title>Induction Phase: Vedolizumab 300 mg</title>
          <description>Vedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase.</description>
        </group>
        <group group_id="E3">
          <title>Maintenance Phase: Induction Placebo to Placebo Q4W</title>
          <description>Participants who received placebo in the Induction Phase and achieved clinical response at Week 10 continued to receive placebo in the Maintenance Phase. Vedolizumab placebo-matching, IV infusion, once every 4 weeks (Q4W), from Week 14 to Week 58.</description>
        </group>
        <group group_id="E4">
          <title>Maintenance Phase: Induction Placebo to Vedolizumab 300 mg Q4W</title>
          <description>Participants who received placebo in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.</description>
        </group>
        <group group_id="E5">
          <title>Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q8W</title>
          <description>Participants who received vedolizumab in the Induction Phase and achieved clinical response at Week 10 continued to receive vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W), at Weeks 14, 22, 30, 38, 46 and 54 and vedolizumab placebo-matching, IV infusion, Q8W, at Weeks 18, 26, 34, 42, 50 and 58 to maintain double-blind.</description>
        </group>
        <group group_id="E6">
          <title>Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q4W</title>
          <description>Participants who received vedolizumab in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="14" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="25" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Gastrointestinal fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Intestinal fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Volvulus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Ileal perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Large intestinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperpyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Granuloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bartholin's abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Liver abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Anal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Mumps</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Foreign body in throat</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="88"/>
              </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="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="60" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="23" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="27" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="63" subjects_at_risk="88"/>
              </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="6" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Protein urine present</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Haematocrit decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Red blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Blood urine present</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>TrialDisclosures@takeda.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/NCT03234907
org study id: Vedolizumab-3034
secondary id: U1111-1195-3932
nct id: NCT03234907
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to assess the safety and efficacy of vedolizumab intravenous
      (IV) infusion as induction treatment in Chinese participants with moderately to severely
      active Crohn's disease (CD) at Week 10.
The drug being tested in this study is called vedolizumab. Vedolizumab will be administered
      as an intravenous (IV) infusion in Chinese participants. This study will investigate the
      efficacy and safety of vedolizumab IV as induction and maintenance therapy in participants
      with moderately to severely active Crohn's Disease (CD).

      The study will enroll approximately 300 moderately to severely active Chinese patients with
      CD.

      Induction Phase: participants will be randomized 2:1 to receive:

        -  Vedolizumab IV 300 mg

        -  Placebo IV

      Participants will receive vedolizumab 300 mg or matching placebo, intravenous (IV) infusion
      at Weeks 0, 2, and 6 in the induction phase. At Week 10, participants will be assessed for
      clinical response. Results of Week 10 clinical response will determine the treatment pathway
      in the maintenance phase.

      Maintenance Phase: participants who achieved clinical response at Week 10 will continue to
      receive the same treatment as they received in Induction Phase; every 8 weeks (Q8W) starting
      at Week 14. Participants who received vedolizumab IV or placebo in the Induction Phase and
      did not achieve clinical response at Week 10 will receive vedolizumab every 4 weeks (Q4W)
      starting at Week 14.

      This multi-center trial will be conducted in China. The overall time to participate in this
      study is 60 weeks. Participants will make multiple visits to the clinic, and will be
      contacted by telephone, 6 months after last dose of study drug for a long-term follow-up
      safety survey.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants With Enhanced Clinical Response in the Induction Phase at Week 10
time frame: Week 10
description: Enhanced clinical response was defined as ≥100-point decrease from Baseline in the Crohn's Disease Activity Index (CDAI) score at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
measure: Percentage of Participants With Clinical Remission in the Induction Phase at Week 10
time frame: Week 10
description: Clinical remission was defined as CDAI score of ≤150 points at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity
arm group label: Induction Phase: Placebo
arm group type: Placebo Comparator
description: Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
arm group label: Induction Phase: Vedolizumab 300 mg
arm group type: Experimental
description: Vedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase.
arm group label: Maintenance Phase: Induction Placebo to Placebo Q4W
arm group type: Placebo Comparator
description: Participants who received placebo in the Induction Phase and achieved clinical response at Week 10 continued to receive placebo in the Maintenance Phase. Vedolizumab placebo-matching, IV infusion, once every 4 weeks (Q4W), from Week 14 to Week 58.
arm group label: Maintenance Phase: Induction Placebo to Vedolizumab 300 mg Q4W
arm group type: Experimental
description: Participants who received placebo in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.
arm group label: Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q8W
arm group type: Experimental
description: Participants who received vedolizumab in the Induction Phase and achieved clinical response at Week 10 continued to receive vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W), at Weeks 14, 22, 30, 38, 46 and 54 and vedolizumab placebo-matching, IV infusion, Q8W, at Weeks 18, 26, 34, 42, 50 and 58 to maintain double-blind.
arm group label: Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q4W
arm group type: Experimental
description: Participants who received vedolizumab in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58.
intervention type: Drug
intervention name: Vedolizumab IV
description: Vedolizumab IV infusion
arm group label: Induction Phase: Placebo
arm group label: Maintenance Phase: Induction Placebo to Placebo Q4W
arm group label: Maintenance Phase: Induction Placebo to Vedolizumab 300 mg Q4W
arm group label: Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q4W
intervention type: Drug
intervention name: Placebo
description: Vedolizumab placebo-matching
arm group label: Induction Phase: Vedolizumab 300 mg
arm group label: Maintenance Phase: Induction Placebo to Placebo Q4W
arm group label: Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q8W
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Study Director Clinical Science
role: Study Director
affiliation: Takeda
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country: China
url: https://clinicaltrials.takeda.com/study-detail/5f6b603b4db2bf003ab4a32b?idFilter=%5B%22Vedolizumab-3034%22%5D
description: To obtain more information on the study, click on this link.
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Vedolizumab
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 