<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/NCT03827655</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-954-2004</org_study_id>
    <secondary_id>2018-003318-42</secondary_id>
    <secondary_id>U1111-1222-4784</secondary_id>
    <nct_id>NCT03827655</nct_id>
  </id_info>
  <brief_title>A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of 2 Dose Regimens of Intravenous TAK-954 for the Prophylaxis and Treatment of Postoperative Gastrointestinal Dysfunction in Patients Undergoing Large- and Small-Bowel Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Takeda Development Center Americas, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main aim of this study is to check for side effects from TAK-954 and whether it speeds up&#xD;
      the recovery of gastrointestinal function after small-bowel or large-bowel resection surgery.&#xD;
&#xD;
      Participants will be treated with TAK-954 before surgery and up to 10 days after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called TAK-954. In this study TAK-954 is being&#xD;
      administered presurgery to evaluate if it can enhance the recovery of GI function postsurgery&#xD;
      in participants undergoing open or laparoscopic-assisted partial small- or large-bowel&#xD;
      resection. In addition, some participants will also receive TAK-954 postoperatively to&#xD;
      evaluate if there is an additional benefit when this drug is administered both pre and&#xD;
      post-surgery.&#xD;
&#xD;
      The study will enroll approximately 180 participants. Participants will be equally randomized&#xD;
      into one of the three remaining parallel treatment arms- which will remain undisclosed to the&#xD;
      participant and study doctor during the study (unless there is an urgent medical need).&#xD;
&#xD;
      All participants will be given intravenous infusion preoperation and daily postoperation&#xD;
      until return of upper and lower GI function or for up to 10 days.&#xD;
&#xD;
      This multi-center trial will be conducted in the United States and Germany. The overall time&#xD;
      to participate in this study is up to 100 days. Participants will be treated with the study&#xD;
      drug for up to 10 days after surgery or until return of GI function post-surgery (whichever&#xD;
      occurs first).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2019</start_date>
  <completion_date type="Actual">May 27, 2022</completion_date>
  <primary_completion_date type="Actual">May 27, 2022</primary_completion_date>
  <phase>Phase 2</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>Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator</measure>
    <time_frame>Day 1 (surgery) up to Day 10 postsurgery</time_frame>
    <description>The time from end of surgery to tolerance of solid food, without first occurrence of vomiting or clinically significant nausea for 1 calendar day after a solid meal (upper GI function) and first spontaneous bowel movement (lower GI function), whichever occurred later up to 10 days postsurgery was observed. Kaplan-Meier survival analysis method was used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator</measure>
    <time_frame>Day 1 (surgery) up to Day 24</time_frame>
    <description>The time from the end of surgery (time the incision is closed) until ready for discharge was defined as time from end of surgery until the participant presented effective intestinal transit (spontaneous bowel movement), tolerated solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal, had satisfactory pain control with oral analgesics, and was medically stable/free of complications. Kaplan-Meier survival analysis method was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From the End of Surgery Until the Discharge Order is Written</measure>
    <time_frame>Day 1 (surgery) up to Day 24</time_frame>
    <description>Kaplan-Meier survival analysis method was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From the End of Surgery to Discharge From Hospital</measure>
    <time_frame>Day 1 (surgery) up to Day 24</time_frame>
    <description>Kaplan-Meier survival analysis method was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator</measure>
    <time_frame>Day 1 (surgery) up to Day 10 postsurgery</time_frame>
    <description>The time from end of surgery to tolerance of solid food was defined as intake of solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal. Kaplan-Meier survival analysis method was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator</measure>
    <time_frame>Day 1 (surgery) up to Day 10 postsurgery</time_frame>
    <description>The time from end of surgery to first spontaneous bowel movement was defined as a stool not induced by the use of enemas or laxatives. Kaplan-Meier survival analysis method was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) &gt;= 5 Days as Assessed by the Investigator</measure>
    <time_frame>Day 1 (surgery) up to Day 10</time_frame>
    <description>Participants unable to tolerate solid foods, take anything by mouth, or requiring insertion or reinsertion of nasogastric (NG) tube at or after 5 days post-surgery. Percentages are rounded off to whole number at the nearest single decimal. Stratified Miettinen and Nurminen approach was used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery</measure>
    <time_frame>Day 1 (surgery) up to Day 24 postsurgery (10 days of treatment period postsurgery plus 14-day observation period post last dose for recurrence of symptoms)</time_frame>
    <description>Participants who required insertion of NG tube postsurgery for drainage and symptom relief in case of persistent nausea and vomiting postsurgery were observed. Percentages are rounded off to whole number at the nearest single decimal. Stratified Miettinen and Nurminen approach was used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From End of Surgery to First Flatus</measure>
    <time_frame>Day 1 (surgery) up to first flatus (up to Day 10 postsurgery)</time_frame>
    <description>Kaplan-Meier survival analysis method was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1</measure>
    <time_frame>Day 1 (surgery): postinfusion</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">209</enrollment>
  <condition>Postoperative Gastrointestinal Dysfunction</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAK-954 0.1 mg/100 mL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-954 0.1 milligrams per 100 milliliters (mg/100 mL), 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAK-954 0.5 mg/100 mL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAK-954 0.1 mg/100 mL + Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAK-954 0.5 mg/100 mL + Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAK-954 Placebo</intervention_name>
    <description>TAK-954 placebo-matching intravenous infusion.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>TAK-954 0.1 mg/100 mL + Placebo</arm_group_label>
    <arm_group_label>TAK-954 0.5 mg/100 mL + Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAK-954</intervention_name>
    <description>TAK-954 intravenous infusion.</description>
    <arm_group_label>TAK-954 0.1 mg/100 mL</arm_group_label>
    <arm_group_label>TAK-954 0.1 mg/100 mL + Placebo</arm_group_label>
    <arm_group_label>TAK-954 0.5 mg/100 mL</arm_group_label>
    <arm_group_label>TAK-954 0.5 mg/100 mL + Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participant is scheduled to undergo a laparoscopic-assisted or open partial small- or&#xD;
             large-bowel resection.&#xD;
&#xD;
          2. Participant's American Society of Anesthesiologists (ASA) physical status&#xD;
             classification is ASA 1 to 3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has significant mechanical bowel obstruction that is not expected to resolve after the&#xD;
             surgery, short bowel syndrome, pre-existing clinically significant GI motility&#xD;
             disorder (example, gastroparesis, scleroderma, chronic intestinal pseudo-obstruction),&#xD;
             uncontrolled diabetes (glycosylated hemoglobin [HbA1c] greater than [&gt;] 10 percent&#xD;
             [%]), has an active gastric pacemaker, or requires parenteral nutrition.&#xD;
&#xD;
          2. Had previous major abdominal surgery (example, gastrectomy, gastric bypass, gastric&#xD;
             sleeve, lap banding, Whipple, pancreatic resection, total/subtotal colectomy,&#xD;
             hemicolectomy, extensive bowel resection).&#xD;
&#xD;
          3. Had a history of radiation therapy to the abdomen or pelvis.&#xD;
&#xD;
          4. Scheduled to undergo any of the following surgeries: low anterior resection, total or&#xD;
             subtotal colectomy, colostomy, ileostomy or reversal of stoma, or has a diagnosis that&#xD;
             requires rectal resection (eg, tumors in the anorectum) and will likely require lower&#xD;
             anterior resection surgery. Participants with planned surgery for which there is no&#xD;
             anticipated significant rectal resection and is, therefore, likely to preserve&#xD;
             anorectal function and continence postsurgery, will likely be eligible for inclusion&#xD;
             in the study if they meet all the study inclusion/exclusion criteria (eg, participants&#xD;
             with lesions not involving the rectum [sigmoid colon and above]).&#xD;
&#xD;
          5. Has pre-existing hepatic disease that meets Child-Pugh Class B (moderate; total score&#xD;
             7 to 9 points) or C (severe; total score 10 to 15 points).&#xD;
&#xD;
          6. Has received alvimopan, erythromycin, prucalopride, metoclopramide, domperidone,&#xD;
             cisapride, mosapride, renzapride, or azithromycin in the 24 hours prior to starting&#xD;
             study drug.&#xD;
&#xD;
          7. Participant has known COVID-19 infection, or suspected COVID-19 infection.&#xD;
&#xD;
          8. Scheduled for abdominal surgery that is classified as emergency.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of South Alabama Medical Center</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>30617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keck School of Medicine</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Irvine Medical Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Community Hospital Medical Center</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Leonard M. Miller School of Medicine</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Colon &amp; Rectal Surgery - Altamonte Springs</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Florida</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Melvin and Bren Simon Cancer Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Memorial Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Hospital</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Hospital</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Health Milton S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HD Research Corp.</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Star Medical</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77089</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Freiburg</name>
      <address>
        <city>Freiburg</city>
        <state>Baden-wuerttemberg</state>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Mannheim</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-wuerttemberg</state>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Regensburg</name>
      <address>
        <city>Regensburg</city>
        <state>Bavaria</state>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Rechts der Isar der Technischen Universitat Munchen</name>
      <address>
        <city>Munchen</city>
        <state>Bayern</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sankt Josef-Hospital</name>
      <address>
        <city>Bochum</city>
        <state>Nordrhein-westfalen</state>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Belgium</country>
    <country>Hungary</country>
  </removed_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5f6b603a4db2bf003ab4a2cf</url>
    <description>To obtain more information on the study, click here/on this link.</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <results_first_submitted>May 26, 2023</results_first_submitted>
  <results_first_submitted_qc>May 26, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 23, 2023</results_first_posted>
  <last_update_submitted>May 26, 2023</last_update_submitted>
  <last_update_submitted_qc>May 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Therapy</keyword>
  <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>March 25, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03827655/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>May 18, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03827655/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 20 investigative sites in Germany and the United States from 07 March 2019 to 27 May 2022.</recruitment_details>
      <pre_assignment_details>Participants with a diagnosis of postoperative gastrointestinal dysfunction were enrolled in a 1:1:1:1:1 ratio into one of the five treatment groups to receive TAK-954 and/or placebo before and after surgery.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once presurgery on Day 1 and once daily postsurgery until return of upper and lower gastrointestinal (GI) function or for up to 10 days.</description>
        </group>
        <group group_id="P2">
          <title>TAK-954 0.1 mg/100 mL</title>
          <description>TAK-954 0.1 milligrams per 100 milliliters (mg/100 mL), 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
        </group>
        <group group_id="P3">
          <title>TAK-954 0.5 mg/100 mL</title>
          <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
        </group>
        <group group_id="P4">
          <title>TAK-954 0.1 mg/100 mL + Placebo</title>
          <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
        </group>
        <group group_id="P5">
          <title>TAK-954 0.5 mg/100 mL + Placebo</title>
          <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="51"/>
                <participants group_id="P4" count="27"/>
                <participants group_id="P5" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Set</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="48"/>
                <participants group_id="P4" count="25"/>
                <participants group_id="P5" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set (FAS)</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="42"/>
                <participants group_id="P4" count="21"/>
                <participants group_id="P5" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Pharmacokinetic (PK) Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="47"/>
                <participants group_id="P4" count="24"/>
                <participants group_id="P5" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="47"/>
                <participants group_id="P4" count="25"/>
                <participants group_id="P5" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</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="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason not Specified</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Randomized Set included all participants who were randomized in the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>TAK-954 placebo-matching, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
        </group>
        <group group_id="B2">
          <title>TAK-954 0.1 mg/100 mL</title>
          <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
        </group>
        <group group_id="B3">
          <title>TAK-954 0.5 mg/100 mL</title>
          <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
        </group>
        <group group_id="B4">
          <title>TAK-954 0.1 mg/100 mL + Placebo</title>
          <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
        </group>
        <group group_id="B5">
          <title>TAK-954 0.5 mg/100 mL + Placebo</title>
          <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
        </group>
        <group group_id="B6">
          <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="52"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="51"/>
            <count group_id="B4" value="27"/>
            <count group_id="B5" value="52"/>
            <count group_id="B6" value="209"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="52"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="27"/>
                    <count group_id="B5" value="52"/>
                    <count group_id="B6" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.9" spread="11.99"/>
                    <measurement group_id="B2" value="55.9" spread="13.83"/>
                    <measurement group_id="B3" value="57.3" spread="14.10"/>
                    <measurement group_id="B4" value="53.7" spread="12.15"/>
                    <measurement group_id="B5" value="53.2" spread="15.28"/>
                    <measurement group_id="B6" value="55.8" spread="13.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="52"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="27"/>
                    <count group_id="B5" value="52"/>
                    <count group_id="B6" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="26"/>
                    <measurement group_id="B6" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="26"/>
                    <measurement group_id="B6" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="52"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="27"/>
                    <count group_id="B5" value="52"/>
                    <count group_id="B6" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="39"/>
                    <measurement group_id="B6" value="161"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="52"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="27"/>
                    <count group_id="B5" value="52"/>
                    <count group_id="B6" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                  </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="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="38"/>
                    <measurement group_id="B6" value="153"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="52"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="27"/>
                    <count group_id="B5" value="52"/>
                    <count group_id="B6" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="52"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="27"/>
                    <count group_id="B5" value="52"/>
                    <count group_id="B6" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="42"/>
                    <measurement group_id="B6" value="173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <population>Number analyzed is the number of participants with data available for analysis at Baseline.</population>
          <units>centimeters (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="47"/>
                    <count group_id="B4" value="25"/>
                    <count group_id="B5" value="50"/>
                    <count group_id="B6" value="196"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="170.83" spread="10.991"/>
                    <measurement group_id="B2" value="173.01" spread="9.273"/>
                    <measurement group_id="B3" value="172.30" spread="9.335"/>
                    <measurement group_id="B4" value="172.23" spread="10.972"/>
                    <measurement group_id="B5" value="172.60" spread="9.603"/>
                    <measurement group_id="B6" value="172.09" spread="9.972"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <population>Number analyzed is the number of participants with data available for analysis at Baseline.</population>
          <units>kilograms (kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="47"/>
                    <count group_id="B4" value="25"/>
                    <count group_id="B5" value="50"/>
                    <count group_id="B6" value="196"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87.25" spread="19.317"/>
                    <measurement group_id="B2" value="82.92" spread="18.066"/>
                    <measurement group_id="B3" value="87.26" spread="15.995"/>
                    <measurement group_id="B4" value="82.84" spread="26.018"/>
                    <measurement group_id="B5" value="85.64" spread="20.416"/>
                    <measurement group_id="B6" value="85.73" spread="19.587"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>BMI=[weight(kg)]/[height(m^2)]</description>
          <population>Number analyzed is the number of participants with data available for analysis at Baseline.</population>
          <units>kilograms per square meter (kg/m^2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="47"/>
                    <count group_id="B4" value="25"/>
                    <count group_id="B5" value="50"/>
                    <count group_id="B6" value="196"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.84" spread="5.920"/>
                    <measurement group_id="B2" value="27.80" spread="6.492"/>
                    <measurement group_id="B3" value="29.45" spread="5.465"/>
                    <measurement group_id="B4" value="27.60" spread="6.904"/>
                    <measurement group_id="B5" value="28.76" spread="6.652"/>
                    <measurement group_id="B6" value="28.93" spread="6.206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator</title>
        <description>The time from end of surgery to tolerance of solid food, without first occurrence of vomiting or clinically significant nausea for 1 calendar day after a solid meal (upper GI function) and first spontaneous bowel movement (lower GI function), whichever occurred later up to 10 days postsurgery was observed. Kaplan-Meier survival analysis method was used.</description>
        <time_frame>Day 1 (surgery) up to Day 10 postsurgery</time_frame>
        <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>TAK-954 placebo-matching, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.1 mg/100 mL</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 0.5 mg/100 mL</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O4">
            <title>TAK-954 0.1 mg/100 mL + Placebo</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
          <group group_id="O5">
            <title>TAK-954 0.5 mg/100 mL + Placebo</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator</title>
          <description>The time from end of surgery to tolerance of solid food, without first occurrence of vomiting or clinically significant nausea for 1 calendar day after a solid meal (upper GI function) and first spontaneous bowel movement (lower GI function), whichever occurred later up to 10 days postsurgery was observed. Kaplan-Meier survival analysis method was used.</description>
          <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.89" lower_limit="1.41" upper_limit="5.79"/>
                    <measurement group_id="O2" value="2.76" lower_limit="1.51" upper_limit="7.85"/>
                    <measurement group_id="O3" value="2.59" lower_limit="0.85" upper_limit="4.97"/>
                    <measurement group_id="O4" value="2.62" lower_limit="1.13" upper_limit="7.59"/>
                    <measurement group_id="O5" value="2.58" lower_limit="1.46" upper_limit="7.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.649</p_value>
            <p_value_desc>P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio&gt;1.</p_value_desc>
            <method>Wald chi-square test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.63</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
            <estimate_desc>Hazard ratios, 90% confidence intervals (CIs) and associated Wald Chi-square p-values between TAK-954 dose levels and placebo were obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.505</p_value>
            <p_value_desc>P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio&gt;1.</p_value_desc>
            <method>Wald chi-square test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.43</ci_upper_limit>
            <estimate_desc>Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator</title>
        <description>The time from the end of surgery (time the incision is closed) until ready for discharge was defined as time from end of surgery until the participant presented effective intestinal transit (spontaneous bowel movement), tolerated solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal, had satisfactory pain control with oral analgesics, and was medically stable/free of complications. Kaplan-Meier survival analysis method was used.</description>
        <time_frame>Day 1 (surgery) up to Day 24</time_frame>
        <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>TAK-954 placebo-matching, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.1 mg/100 mL</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 0.5 mg/100 mL</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O4">
            <title>TAK-954 0.1 mg/100 mL + Placebo</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
          <group group_id="O5">
            <title>TAK-954 0.5 mg/100 mL + Placebo</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator</title>
          <description>The time from the end of surgery (time the incision is closed) until ready for discharge was defined as time from end of surgery until the participant presented effective intestinal transit (spontaneous bowel movement), tolerated solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal, had satisfactory pain control with oral analgesics, and was medically stable/free of complications. Kaplan-Meier survival analysis method was used.</description>
          <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.03" lower_limit="1.41" upper_limit="16.83"/>
                    <measurement group_id="O2" value="2.82" lower_limit="1.51" upper_limit="9.68"/>
                    <measurement group_id="O3" value="2.69" lower_limit="0.85" upper_limit="8.79"/>
                    <measurement group_id="O4" value="2.94" lower_limit="1.47" upper_limit="7.73"/>
                    <measurement group_id="O5" value="2.77" lower_limit="1.51" upper_limit="7.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.449</p_value>
            <p_value_desc>P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio&gt;1.</p_value_desc>
            <method>Wald chi-square test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>1.49</ci_upper_limit>
            <estimate_desc>Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.507</p_value>
            <p_value_desc>P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio&gt;1.</p_value_desc>
            <method>Wald chi-square test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.44</ci_upper_limit>
            <estimate_desc>Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From the End of Surgery Until the Discharge Order is Written</title>
        <description>Kaplan-Meier survival analysis method was used.</description>
        <time_frame>Day 1 (surgery) up to Day 24</time_frame>
        <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>TAK-954 placebo-matching, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.1 mg/100 mL</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 0.5 mg/100 mL</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O4">
            <title>TAK-954 0.1 mg/100 mL + Placebo</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
          <group group_id="O5">
            <title>TAK-954 0.5 mg/100 mL + Placebo</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From the End of Surgery Until the Discharge Order is Written</title>
          <description>Kaplan-Meier survival analysis method was used.</description>
          <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.86" lower_limit="1.62" upper_limit="16.72"/>
                    <measurement group_id="O2" value="3.95" lower_limit="1.88" upper_limit="10.89"/>
                    <measurement group_id="O3" value="2.81" lower_limit="0.89" upper_limit="11.09"/>
                    <measurement group_id="O4" value="2.94" lower_limit="1.47" upper_limit="7.81"/>
                    <measurement group_id="O5" value="3.33" lower_limit="1.56" upper_limit="14.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.406</p_value>
            <p_value_desc>P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio&gt;1.</p_value_desc>
            <method>Wald chi-square test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.05</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.52</ci_upper_limit>
            <estimate_desc>Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.880</p_value>
            <p_value_desc>P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio&gt;1.</p_value_desc>
            <method>Wald chi-square test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.77</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.54</ci_lower_limit>
            <ci_upper_limit>1.11</ci_upper_limit>
            <estimate_desc>Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From the End of Surgery to Discharge From Hospital</title>
        <description>Kaplan-Meier survival analysis method was used.</description>
        <time_frame>Day 1 (surgery) up to Day 24</time_frame>
        <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>TAK-954 placebo-matching, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.1 mg/100 mL</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 0.5 mg/100 mL</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O4">
            <title>TAK-954 0.1 mg/100 mL + Placebo</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
          <group group_id="O5">
            <title>TAK-954 0.5 mg/100 mL + Placebo</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From the End of Surgery to Discharge From Hospital</title>
          <description>Kaplan-Meier survival analysis method was used.</description>
          <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.96" lower_limit="1.72" upper_limit="16.76"/>
                    <measurement group_id="O2" value="4.06" lower_limit="1.97" upper_limit="10.89"/>
                    <measurement group_id="O3" value="2.89" lower_limit="1.00" upper_limit="11.11"/>
                    <measurement group_id="O4" value="3.05" lower_limit="1.58" upper_limit="7.83"/>
                    <measurement group_id="O5" value="3.39" lower_limit="1.70" upper_limit="14.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.446</p_value>
            <p_value_desc>P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio&gt;1.</p_value_desc>
            <method>Wald chi-square test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.48</ci_upper_limit>
            <estimate_desc>Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.892</p_value>
            <p_value_desc>P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio&gt;1.</p_value_desc>
            <method>Wald chi-square test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.76</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>1.09</ci_upper_limit>
            <estimate_desc>Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator</title>
        <description>The time from end of surgery to tolerance of solid food was defined as intake of solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal. Kaplan-Meier survival analysis method was used.</description>
        <time_frame>Day 1 (surgery) up to Day 10 postsurgery</time_frame>
        <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>TAK-954 placebo-matching, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.1 mg/100 mL</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 0.5 mg/100 mL</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O4">
            <title>TAK-954 0.1 mg/100 mL + Placebo</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
          <group group_id="O5">
            <title>TAK-954 0.5 mg/100 mL + Placebo</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator</title>
          <description>The time from end of surgery to tolerance of solid food was defined as intake of solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal. Kaplan-Meier survival analysis method was used.</description>
          <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.82" lower_limit="1.41" upper_limit="5.79"/>
                    <measurement group_id="O2" value="2.76" lower_limit="1.51" upper_limit="7.85"/>
                    <measurement group_id="O3" value="2.36" lower_limit="0.74" upper_limit="4.97"/>
                    <measurement group_id="O4" value="2.15" lower_limit="1.13" upper_limit="7.59"/>
                    <measurement group_id="O5" value="2.55" lower_limit="1.32" upper_limit="7.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.760</p_value>
            <p_value_desc>P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio&gt;1.</p_value_desc>
            <method>Wald chi-square test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>1.23</ci_upper_limit>
            <estimate_desc>Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.810</p_value>
            <p_value_desc>P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio&gt;1.</p_value_desc>
            <method>Wald chi-squared test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.83</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>1.18</ci_upper_limit>
            <estimate_desc>Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator</title>
        <description>The time from end of surgery to first spontaneous bowel movement was defined as a stool not induced by the use of enemas or laxatives. Kaplan-Meier survival analysis method was used.</description>
        <time_frame>Day 1 (surgery) up to Day 10 postsurgery</time_frame>
        <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>TAK-954 placebo-matching, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.1 mg/100 mL</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 0.5 mg/100 mL</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O4">
            <title>TAK-954 0.1 mg/100 mL + Placebo</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
          <group group_id="O5">
            <title>TAK-954 0.5 mg/100 mL + Placebo</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator</title>
          <description>The time from end of surgery to first spontaneous bowel movement was defined as a stool not induced by the use of enemas or laxatives. Kaplan-Meier survival analysis method was used.</description>
          <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.56" lower_limit="0.16" upper_limit="7.89"/>
                    <measurement group_id="O2" value="1.73" lower_limit="0.11" upper_limit="3.81"/>
                    <measurement group_id="O3" value="1.11" lower_limit="0.08" upper_limit="4.82"/>
                    <measurement group_id="O4" value="1.72" lower_limit="0.20" upper_limit="3.23"/>
                    <measurement group_id="O5" value="1.74" lower_limit="0.53" upper_limit="4.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.288</p_value>
            <p_value_desc>P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio&gt;1.</p_value_desc>
            <method>Wald chi-square test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.13</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.64</ci_upper_limit>
            <estimate_desc>Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.453</p_value>
            <p_value_desc>P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio&gt;1.</p_value_desc>
            <method>Wald chi-square test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.47</ci_upper_limit>
            <estimate_desc>Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) &gt;= 5 Days as Assessed by the Investigator</title>
        <description>Participants unable to tolerate solid foods, take anything by mouth, or requiring insertion or reinsertion of nasogastric (NG) tube at or after 5 days post-surgery. Percentages are rounded off to whole number at the nearest single decimal. Stratified Miettinen and Nurminen approach was used for analysis.</description>
        <time_frame>Day 1 (surgery) up to Day 10</time_frame>
        <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>TAK-954 placebo-matching, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.1 mg/100 mL</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 0.5 mg/100 mL</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O4">
            <title>TAK-954 0.1 mg/100 mL + Placebo</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
          <group group_id="O5">
            <title>TAK-954 0.5 mg/100 mL + Placebo</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) &gt;= 5 Days as Assessed by the Investigator</title>
          <description>Participants unable to tolerate solid foods, take anything by mouth, or requiring insertion or reinsertion of nasogastric (NG) tube at or after 5 days post-surgery. Percentages are rounded off to whole number at the nearest single decimal. Stratified Miettinen and Nurminen approach was used for analysis.</description>
          <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9"/>
                    <measurement group_id="O2" value="8.7"/>
                    <measurement group_id="O3" value="2.4"/>
                    <measurement group_id="O4" value="4.8"/>
                    <measurement group_id="O5" value="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.046</p_value>
            <p_value_desc>P-value was derived using a one-sided test with Ha: Risk Difference&lt;0.</p_value_desc>
            <method>Stratified Miettinen and Nurminen</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-0.09</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.17</ci_lower_limit>
            <ci_upper_limit>0.00</ci_upper_limit>
            <estimate_desc>The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.516</p_value>
            <p_value_desc>P-value was derived using a one-sided test with Ha: Risk Difference&lt;0.</p_value_desc>
            <method>Stratified Miettinen and Nurminen</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>0.00</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.11</ci_upper_limit>
            <estimate_desc>The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery</title>
        <description>Participants who required insertion of NG tube postsurgery for drainage and symptom relief in case of persistent nausea and vomiting postsurgery were observed. Percentages are rounded off to whole number at the nearest single decimal. Stratified Miettinen and Nurminen approach was used for analysis.</description>
        <time_frame>Day 1 (surgery) up to Day 24 postsurgery (10 days of treatment period postsurgery plus 14-day observation period post last dose for recurrence of symptoms)</time_frame>
        <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>TAK-954 placebo-matching, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.1 mg/100 mL</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 0.5 mg/100 mL</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O4">
            <title>TAK-954 0.1 mg/100 mL + Placebo</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
          <group group_id="O5">
            <title>TAK-954 0.5 mg/100 mL + Placebo</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery</title>
          <description>Participants who required insertion of NG tube postsurgery for drainage and symptom relief in case of persistent nausea and vomiting postsurgery were observed. Percentages are rounded off to whole number at the nearest single decimal. Stratified Miettinen and Nurminen approach was used for analysis.</description>
          <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="4.8"/>
                    <measurement group_id="O4" value="4.8"/>
                    <measurement group_id="O5" value="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.296</p_value>
            <p_value_desc>P-value was derived using a one-sided test with Ha: Risk Difference&lt;0.</p_value_desc>
            <method>Stratified Miettinen and Nurminen</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-0.03</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.12</ci_lower_limit>
            <ci_upper_limit>0.06</ci_upper_limit>
            <estimate_desc>The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.677</p_value>
            <p_value_desc>P-value was derived using a one-sided test with Ha: Risk Difference&lt;0.</p_value_desc>
            <method>Stratified Miettinen and Nurminen</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>0.03</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.07</ci_lower_limit>
            <ci_upper_limit>0.13</ci_upper_limit>
            <estimate_desc>The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From End of Surgery to First Flatus</title>
        <description>Kaplan-Meier survival analysis method was used.</description>
        <time_frame>Day 1 (surgery) up to first flatus (up to Day 10 postsurgery)</time_frame>
        <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>TAK-954 placebo-matching, 60-minute IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.1 mg/100 mL</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 0.5 mg/100 mL</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O4">
            <title>TAK-954 0.1 mg/100 mL + Placebo</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
          <group group_id="O5">
            <title>TAK-954 0.5 mg/100 mL + Placebo</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From End of Surgery to First Flatus</title>
          <description>Kaplan-Meier survival analysis method was used.</description>
          <population>FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food).</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.21" lower_limit="0.06" upper_limit="6.22"/>
                    <measurement group_id="O2" value="1.26" lower_limit="0.28" upper_limit="7.62"/>
                    <measurement group_id="O3" value="0.96" lower_limit="0.08" upper_limit="3.04"/>
                    <measurement group_id="O4" value="1.18" lower_limit="0.20" upper_limit="2.82"/>
                    <measurement group_id="O5" value="1.12" lower_limit="0.02" upper_limit="3.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.338</p_value>
            <p_value_desc>P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio&gt;1.</p_value_desc>
            <method>Wald chi-square test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.10</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>1.57</ci_upper_limit>
            <estimate_desc>Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.422</p_value>
            <p_value_desc>P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio&gt;1.</p_value_desc>
            <method>Wald chi-square test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.04</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.49</ci_upper_limit>
            <estimate_desc>Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1</title>
        <time_frame>Day 1 (surgery): postinfusion</time_frame>
        <population>PK Analysis Set included all participants who were randomized, received at least 1 dose and had at least 1 measurable post-dose plasma for TAK-954. Overall number analyzed is the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>TAK-954 0.1 mg/100 mL</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O2">
            <title>TAK-954 0.5 mg/100 mL</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
          </group>
          <group group_id="O3">
            <title>TAK-954 0.1 mg/100 mL + Placebo</title>
            <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
          <group group_id="O4">
            <title>TAK-954 0.5 mg/100 mL + Placebo</title>
            <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
          </group>
        </group_list>
        <measure>
          <title>Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1</title>
          <population>PK Analysis Set included all participants who were randomized, received at least 1 dose and had at least 1 measurable post-dose plasma for TAK-954. Overall number analyzed is the number of participants with data available for analyses.</population>
          <units>picograms per milliliter (pg/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1190" spread="480"/>
                    <measurement group_id="O2" value="5220" spread="1810"/>
                    <measurement group_id="O3" value="2500" spread="4140"/>
                    <measurement group_id="O4" value="12000" spread="28500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug up to Day 100</time_frame>
      <desc>All-cause Mortality: All participants enrolled in the study. Serious and Other Adverse Events: Safety Set included all participants who were randomized and received at least 1 dose of double-blind study medication.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once presurgery on Day 1 and once daily postsurgery until return of upper and lower gastrointestinal (GI) function or for up to 10 days.</description>
        </group>
        <group group_id="E2">
          <title>TAK-954 0.1 mg/100 mL</title>
          <description>TAK-954 0.1 milligrams per 100 milliliters (mg/100 mL), 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
        </group>
        <group group_id="E3">
          <title>TAK-954 0.5 mg/100 mL</title>
          <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.</description>
        </group>
        <group group_id="E4">
          <title>TAK-954 0.1 mg/100 mL + Placebo</title>
          <description>TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
        </group>
        <group group_id="E5">
          <title>TAK-954 0.5 mg/100 mL + Placebo</title>
          <description>TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 25.0</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="52"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Intra-abdominal fluid collection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Intra-abdominal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Mechanical ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Small intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anastomotic leak</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Gastrointestinal stoma complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Postoperative delirium</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Postoperative ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Wound evisceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Prerenal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Urinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Drug reaction with eosinophilia and systemic symptoms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 25.0</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="46" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="39" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="21" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="41" subjects_at_risk="50"/>
              </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="7" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="19" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anaemia postoperative</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Postoperative ileus</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Procedural hypertension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Procedural hypotension</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Procedural nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Urine output decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="48"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="50"/>
              </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/NCT03827655
org study id: TAK-954-2004
secondary id: 2018-003318-42
secondary id: U1111-1222-4784
nct id: NCT03827655
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The main aim of this study is to check for side effects from TAK-954 and whether it speeds up
      the recovery of gastrointestinal function after small-bowel or large-bowel resection surgery.

      Participants will be treated with TAK-954 before surgery and up to 10 days after surgery.
The drug being tested in this study is called TAK-954. In this study TAK-954 is being
      administered presurgery to evaluate if it can enhance the recovery of GI function postsurgery
      in participants undergoing open or laparoscopic-assisted partial small- or large-bowel
      resection. In addition, some participants will also receive TAK-954 postoperatively to
      evaluate if there is an additional benefit when this drug is administered both pre and
      post-surgery.

      The study will enroll approximately 180 participants. Participants will be equally randomized
      into one of the three remaining parallel treatment arms- which will remain undisclosed to the
      participant and study doctor during the study (unless there is an urgent medical need).

      All participants will be given intravenous infusion preoperation and daily postoperation
      until return of upper and lower GI function or for up to 10 days.

      This multi-center trial will be conducted in the United States and Germany. The overall time
      to participate in this study is up to 100 days. Participants will be treated with the study
      drug for up to 10 days after surgery or until return of GI function post-surgery (whichever
      occurs first).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator
time frame: Day 1 (surgery) up to Day 10 postsurgery
description: The time from end of surgery to tolerance of solid food, without first occurrence of vomiting or clinically significant nausea for 1 calendar day after a solid meal (upper GI function) and first spontaneous bowel movement (lower GI function), whichever occurred later up to 10 days postsurgery was observed. Kaplan-Meier survival analysis method was used.
measure: Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator
time frame: Day 1 (surgery) up to Day 24
description: The time from the end of surgery (time the incision is closed) until ready for discharge was defined as time from end of surgery until the participant presented effective intestinal transit (spontaneous bowel movement), tolerated solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal, had satisfactory pain control with oral analgesics, and was medically stable/free of complications. Kaplan-Meier survival analysis method was used.
measure: Time From the End of Surgery Until the Discharge Order is Written
time frame: Day 1 (surgery) up to Day 24
description: Kaplan-Meier survival analysis method was used.
measure: Time From the End of Surgery to Discharge From Hospital
time frame: Day 1 (surgery) up to Day 24
description: Kaplan-Meier survival analysis method was used.
measure: Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator
time frame: Day 1 (surgery) up to Day 10 postsurgery
description: The time from end of surgery to tolerance of solid food was defined as intake of solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal. Kaplan-Meier survival analysis method was used.
measure: Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator
time frame: Day 1 (surgery) up to Day 10 postsurgery
description: The time from end of surgery to first spontaneous bowel movement was defined as a stool not induced by the use of enemas or laxatives. Kaplan-Meier survival analysis method was used.
measure: Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) >= 5 Days as Assessed by the Investigator
time frame: Day 1 (surgery) up to Day 10
description: Participants unable to tolerate solid foods, take anything by mouth, or requiring insertion or reinsertion of nasogastric (NG) tube at or after 5 days post-surgery. Percentages are rounded off to whole number at the nearest single decimal. Stratified Miettinen and Nurminen approach was used for analysis.
measure: Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery
time frame: Day 1 (surgery) up to Day 24 postsurgery (10 days of treatment period postsurgery plus 14-day observation period post last dose for recurrence of symptoms)
description: Participants who required insertion of NG tube postsurgery for drainage and symptom relief in case of persistent nausea and vomiting postsurgery were observed. Percentages are rounded off to whole number at the nearest single decimal. Stratified Miettinen and Nurminen approach was used for analysis.
measure: Time From End of Surgery to First Flatus
time frame: Day 1 (surgery) up to first flatus (up to Day 10 postsurgery)
description: Kaplan-Meier survival analysis method was used.
measure: Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1
time frame: Day 1 (surgery): postinfusion
arm group label: Placebo
arm group type: Placebo Comparator
description: TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.
arm group label: TAK-954 0.1 mg/100 mL
arm group type: Experimental
description: TAK-954 0.1 milligrams per 100 milliliters (mg/100 mL), 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.
arm group label: TAK-954 0.5 mg/100 mL
arm group type: Experimental
description: TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.
arm group label: TAK-954 0.1 mg/100 mL + Placebo
arm group type: Experimental
description: TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.
arm group label: TAK-954 0.5 mg/100 mL + Placebo
arm group type: Experimental
description: TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.
intervention type: Drug
intervention name: TAK-954 Placebo
description: TAK-954 placebo-matching intravenous infusion.
arm group label: Placebo
arm group label: TAK-954 0.1 mg/100 mL + Placebo
arm group label: TAK-954 0.5 mg/100 mL + Placebo
intervention type: Drug
intervention name: TAK-954
description: TAK-954 intravenous infusion.
arm group label: TAK-954 0.1 mg/100 mL
arm group label: TAK-954 0.1 mg/100 mL + Placebo
arm group label: TAK-954 0.5 mg/100 mL
arm group label: TAK-954 0.5 mg/100 mL + Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Takeda
facility: 
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country: Germany
country: United States
country: Belgium
country: Hungary
url: https://clinicaltrials.takeda.com/study-detail/5f6b603a4db2bf003ab4a2cf
description: To obtain more information on the study, click here/on this link.
responsible party type: Sponsor
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: 