Safety and Efficacy of TU-100 as an Adjunct to an Enhance... | NCT04742907

NCT04742907

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TU-100 15 g/day	Experimental	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).	Drug: TU-100
TU-100 7.5 g/day	Experimental	Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).	Drug: TU-100
Placebo	Placebo Comparator	Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
TU-100	Drug	Treatment with investigational product	TU-100 15 g/day TU-100 7.5 g/day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Gastrointestinal Recovery (GIR)	Time to achieve recovery of GI motility as measured by a composite endpoint representing upper AND lower GI recovery	From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

Secondary Outcomes

Measure	Description	Time Frame
Time to GIR Responses	Time to achieve first toleration of solid diet AND first bowel movement (Time to GI-2), time to first toleration of clear liquids, and time to absence of distension and presence of bowel sounds and flatus	From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

Other Outcomes

Measure	Description	Time Frame
Subject-Reported Occurrence of Nausea	Subjects will record the occurrence of nausea in their eDiaries on all postoperative in-hospital days.	From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
Subject-Reported Bothersomeness of Nausea

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female ≥ 18 years of age
Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP; must be able and willing to use at least 1 highly effective method of contraception during the study and for 30 days after the last dose of study drug
American Society of Anesthesiologists Physical Status Score of 1 to 3
Scheduled for an elective BR via open or laparoscopic approach
Ability to understand the study procedures, have agreed to participate in the study program, and have voluntarily provided informed consent

Exclusion Criteria:

Scheduled for a BR that is not listed in this protocol
Requires any additional resections beyond the intestine (eg, hepatectomy, distal pancreatectomy, pancreaticoduodenectomy, gastric resection, uterine resection), or concomitant surgeries (with the exception of biopsies)
Requires the formation of a stoma (ileostomy or colostomy)
History of surgeries, illness, or behavior (eg, depression, psychosis) that in the opinion of the investigator might confound the study results or pose additional risk in administering the study procedures
Have a functional colostomy or ileostomy
Diagnosed with advanced or metastatic colon cancer (Stage IV by tumor, node, and metastasis classification)
Positive coronavirus disease 2019 (COVID-19) test
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including human immunodeficiency virus (HIV)), diabetes, symptomatic congestive heart failure and ejection fraction < 35%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with protocol requirements
Chronic pain syndrome unrelated to the planned surgery requiring consistent management with analgesics and/or other non-pharmacologic modalities
Myocardial infarction within 3 months
Corrected QT interval > 500 msec
Diabetic gastroparesis
Compromised immune system, either from treatment with corticosteroids or other immunosuppressive agent within 2 weeks of surgery or from immunosuppressive disease (HIV)
Pregnant (identified by a positive serum pregnancy test) or lactating, or are not postmenopausal (no menses for at least 1 year) and are of childbearing potential and not using an accepted method of birth control (surgical sterilization, intrauterine contraceptive device, oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam or abstinence)
Participated in another investigational drug/biologic or medical device study within 30 days of surgery or will be enrolled in another investigational drug or medical device study, or any study in which active subject participation is required outside routine hospital data collection during the course of the study
Illicit drug use or alcohol abuse based on medical history, or currently engaged in illicit drug use or alcohol abuse
Uses of supplemental ginger, ginseng, or Zanthoxylum fruit within 72 hours before randomization
Has a history of allergic reactions to ginseng, ginger, Zanthoxylum fruit, or lactose
Has clinical symptoms of lactose intolerance after ingesting milk or milk-containing products (abdominal pain, flatulence, diarrhea)
Unwilling or unable to comply with procedures described in this protocol or is otherwise unacceptable for enrollment in the opinion of the investigator
Has a history of previous surgeries, illness (interstitial pneumonia), or behavior (depression, psychosis) that, in the opinion of the investigator, might confound the study results or pose additional risk in administering the study procedures

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Florence Site		Florence	Alabama	35630	United States
Gilbert Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41114550	Derived	Nedeljkovic SS, Silinsky JD, Nagle D, Lee SW, Ayad S, Segura-Vasi AM, Fleshner PR, Choti MA, Wren SM, Kosaka B Pharm J, Tanaka Y, Li YP, Rachfal AW, Techner LM, Gan TJ, Fichera A, Michelassi F. Evaluation of TU-100 (Daikenchuto), a Traditional Japanese Kampo Medicine, as an Adjunct to Enhanced Recovery After Surgery, for Acceleration of Gastrointestinal Recovery After Bowel Resection: Results of a Proof-of-Concept, Phase 2, Randomized, Double-Blinded, Placebo-Controlled Trial. Dis Colon Rectum. 2026 Jan 1;69(1):73-86. doi: 10.1097/DCR.0000000000003990. Epub 2025 Oct 20.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	TU-100 15 g/Day	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier). TU-100: Treatment with investigational product
FG001	TU-100 7.5 g/Day

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 21, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).

TU-100: Treatment with investigational product

Baseline analysis population includes all randomized subjects who were administered at least one dose of study treatment (safety analysis set).

Arm/Group Information

ID	Title	Description
BG000	TU-100 15 g/Day	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier). TU-100: Treatment with investigational product
BG001	TU-100 7.5 g/Day	Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier). TU-100: Treatment with investigational product
BG002	Placebo	Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier). Placebo: Treatment with placebo product
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG000132 ParticipantsBG001130 ParticipantsBG002130 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000132 ParticipantsBG001130 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000132 ParticipantsBG001130 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000132 ParticipantsBG001130 ParticipantsBG002

BMI

One subject in 7.5 g/day is excluded from the BMI calculation due to missing height.

Mean

Standard Deviation

kg/m2

Title	Denominators	Categories
	ParticipantsBG000132 ParticipantsBG001129 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to Gastrointestinal Recovery (GIR)

Time to achieve recovery of GI motility as measured by a composite endpoint representing upper AND lower GI recovery

Analysis population includes subjects in the Full Analysis Set in each treatment group who receive at least 1 dose of study medication, who underwent an elective bowel resection surgery as specified in the protocol, and who provided at least 1 post-surgery assessment of the primary endpoint (TGIR) during the treatment period.

Posted

Median

90% Confidence Interval

hours

From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

ID	Title	Description
OG000	TU-100 15 g/Day	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier). TU-100: Treatment with investigational product
OG001	TU-100 7.5 g/Day	Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier). TU-100: Treatment with investigational product
OG002	Placebo	Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier). Placebo: Treatment with placebo product

Units	Counts
Participants	OG000132 OG001128 OG002130

Title

Denominators

Categories

Title	Measurements
	OG00032.6(29.7 to 41.2) OG00130.8(28.1 to 35.3) OG00233.4(29.1 to 40.9)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Chi-squared		0.767	P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: hazard ratio (HR) = 1 vs. Ha: HR > 1	Cox Proportional Hazard	0.91			2-Sided	90	0.74	1.12			Hazard ratio and confidence intervals (CIs) are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.		Superiority

Secondary

Time to GIR Responses

Time to achieve first toleration of solid diet AND first bowel movement (Time to GI-2), time to first toleration of clear liquids, and time to absence of distension and presence of bowel sounds and flatus

Posted

Median

90% Confidence Interval

hours

From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

ID	Title	Description
OG000	TU-100 15 g/Day	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
OG001	TU-100 7.5 g/Day	Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
OG002	Placebo	Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).

Secondary

Time to Discharge

Time at which the subject is considered ready for discharge by the investigator based solely on GI recovery (Time to ready for discharge), and time at which the investigator writes discharge order for the subject (Time to discharge order written)

Posted

Median

90% Confidence Interval

hours

From surgery to hospital discharge

ID	Title	Description
OG000	TU-100 15 g/Day	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
OG001	TU-100 7.5 g/Day	Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
OG002	Placebo	Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).

Secondary

GIR Outcome Related to Length of Hospitalization (Mean)

Mean number of days that the subject stayed in the hospital calculated based on calendar day of discharge order written

Posted

Mean

Standard Deviation

days

From surgery to hospital discharge

ID	Title	Description
OG000	TU-100 15 g/Day	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier). TU-100: Treatment with investigational product
OG001	TU-100 7.5 g/Day	Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier). TU-100: Treatment with investigational product
OG002	Placebo	Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier). Placebo: Treatment with placebo product

Secondary

GIR Outcome Related to Length of Hospitalization (Median)

Median number of days that the subject stayed in the hospital calculated based on calendar day of discharge order written

Posted

Median

Full Range

days

From surgery to hospital discharge

ID	Title	Description
OG000	TU-100 15 g/Day	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier). TU-100: Treatment with investigational product
OG001	TU-100 7.5 g/Day	Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier). TU-100: Treatment with investigational product
OG002	Placebo	Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier). Placebo: Treatment with placebo product

Secondary

Percentage of GIR Responders

Percentage of subjects who achieve GIR (GIR responders) by day

Analysis population includes subjects in the Full Analysis population in each treatment group who receive at least 1 dose of study medication, who underwent an elective BR surgery as specified in the protocol, and who provided at least 1 post-surgery assessment of the primary endpoint (TGIR) during the treatment period.

Posted

Number

percentage of subjects

From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

ID	Title	Description
OG000	TU-100 15 g/Day	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
OG001	TU-100 7.5 g/Day	Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
OG002	Placebo	Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).

Secondary

POI-related Morbidity

Primary POI that is not secondary to surgical complication, such as anastomotic leak, abscess formation, or sepsis that requires readmission within 7 days of discharge, or need for postoperative nasal gastric tube insertion to manage symptoms of POI (vomiting/retching, abdominal distension)

Analysis population includes subjects in the Full Analysis population in each treatment group who receive at least 1 dose of study medication, who underwent an elective BR surgery as specified in the protocol, and who provided at least 1 post-surgery assessment of the primary endpoint (TGIR) during the treatment period.

Posted

Count of Participants

Participants

From the day after surgery to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)

ID	Title	Description
OG000	TU-100 15 g/Day	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier). TU-100: Treatment with investigational product
OG001	TU-100 7.5 g/Day	Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier). TU-100: Treatment with investigational product
OG002	Placebo

Secondary

Number of Participants With Adverse Events

Number of patients with adverse events (AEs) observed following administration of TU-100.

Analysis population includes all randomized subjects who were administered at least one dose of study treatment (safety analysis set). More details on patient incidence of adverse events (AEs) observed following administration of TU-100 is entered in AE section.

Posted

Count of Participants

Participants

From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)

ID	Title	Description
OG000	TU-100 15 g/Day	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier). TU-100: Treatment with investigational product
OG001	TU-100 7.5 g/Day	Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier). TU-100: Treatment with investigational product
OG002	Placebo	Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier). Placebo: Treatment with placebo product

Other Pre-specified

Subject-Reported Occurrence of Nausea

Subjects will record the occurrence of nausea in their eDiaries on all postoperative in-hospital days.

Analysis population includes subjects in the Full Analysis population in each treatment group who receive at least 1 dose of study medication, who underwent an elective BR surgery as specified in the protocol, and who answered to the questionnaire through the eDiaries. The questionnaire is only answered during hospital stays, and data is no longer collected once the subjects are discharged. Number Analyzed for each day represents number of subject answered the questionnaire for the day.

Posted

Count of Participants

Participants

From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

ID	Title	Description
OG000	TU-100 15 g/Day	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
OG001	TU-100 7.5 g/Day	Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
OG002	Placebo	Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).

Other Pre-specified

Subject-Reported Bothersomeness of Nausea

Subjects who answered that they felt nauseous will record bothersomeness of nausea in their eDiaries on all postoperative in-hospital days. Bothersomeness is measured on a scale of 0-10 with 10 being the most bothersome.

Analysis population includes subjects in the Full Analysis population in each treatment group who receive at least 1 dose of study medication, who underwent an elective BR surgery as specified in the protocol, and who answered that they felt nausea on the day in the questionnaire through the eDiaries. Data is collected during hospital stays, and no longer collected once the subjects are discharged. Number Analyzed for each day represents number of subject with data for the day.

Posted

Least Squares Mean

Standard Error

score of nausea bothersomeness

From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

ID	Title	Description
OG000	TU-100 15 g/Day	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
OG001	TU-100 7.5 g/Day	Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
OG002	Placebo

Other Pre-specified

Subject-Reported Occurrence of Abdominal Bloating

Subjects will record the occurrence of abdominal bloating in their eDiaries on all postoperative in-hospital days.

Analysis population includes subjects in the Full Analysis population in each treatment group who receive at least 1 dose of study medication, who underwent an elective BR surgery as specified in the protocol, and who answered to the questionnaire through the eDiaries. The questionnaire is only answered during hospital stays, and data is no longer collected once the subjects are discharged. Number Analyzed for each day represents number of subject answered the questionnaire for the day.

Posted

Count of Participants

Participants

From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

ID	Title	Description
OG000	TU-100 15 g/Day	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
OG001	TU-100 7.5 g/Day	Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
OG002	Placebo	Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).

Other Pre-specified

Subject-Reported Bothersomeness of Abdominal Bloating

Subjects who answered that they felt bloated will record bothersomeness of abdominal bloating in their eDiaries on all postoperative in-hospital days. Bothersomeness is measured on a scale of 0-10 with 10 being the most bothersome.

Analysis population includes subjects in the Full Analysis population in each treatment group who receive at least 1 dose of study medication, who underwent an elective BR surgery as specified in the protocol, and who answered that they felt nausea on the day in the questionnaire through the eDiaries. Data is collected during hospital stays, and no longer collected once the subjects are discharged. Number Analyzed for each day represents number of subject with data for the day.

Posted

Least Squares Mean

Standard Error

score of bloating bothersomeness

From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)

ID	Title	Description
OG000	TU-100 15 g/Day	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
OG001	TU-100 7.5 g/Day	Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier).
OG002	Placebo

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	TU-100 15 g/Day	Subjects will receive a total daily dose of TU-100 5 g TID until hospital discharge or ≤ 10 days (whichever is earlier). TU-100: Treatment with investigational product	132	19	132	29	132
EG001	TU-100 7.5 g/Day	Subjects will receive a total daily dose of TU-100 2.5 g TID until hospital discharge or ≤ 10 days (whichever is earlier). TU-100: Treatment with investigational product	130	14	130	39	130
EG002	Placebo	Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier). Placebo: Treatment with placebo product	130	9	130	39	130

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA version 27.0	Systematic Assessment	EG0008 affected132 at risk EG0013 affected130 at risk EG0023 affected130 at risk
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected130 at risk EG0020 affected130 at risk
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA version 27.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected130 at risk EG0021 affected130 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0002 affected132 at risk EG0011 affected130 at risk EG0020 affected130 at risk
Perirectal abscess	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected130 at risk EG0020 affected130 at risk
Pneumonia	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected130 at risk EG0020 affected130 at risk
Sepsis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected130 at risk EG0020 affected130 at risk
Urinary tract infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected130 at risk EG0020 affected130 at risk
Abdominal infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected130 at risk EG0021 affected130 at risk
Clostridium difficile infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected130 at risk EG0020 affected130 at risk
Pelvic abscess	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected130 at risk EG0021 affected130 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected130 at risk EG0020 affected130 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected130 at risk EG0020 affected130 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected130 at risk EG0020 affected130 at risk
Haematochezia	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0012 affected130 at risk EG0021 affected130 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected130 at risk EG0020 affected130 at risk
Intestinal mucosal tear	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected130 at risk EG0020 affected130 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected130 at risk EG0020 affected130 at risk
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected130 at risk EG0020 affected130 at risk
Ascites	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected130 at risk EG0020 affected130 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected130 at risk EG0021 affected130 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected130 at risk EG0021 affected130 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 affected132 at risk EG0012 affected130 at risk EG0021 affected130 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected130 at risk EG0020 affected130 at risk
Pelvic haematoma	Reproductive system and breast disorders	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected130 at risk EG0020 affected130 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected130 at risk EG0020 affected130 at risk
Migraine	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected130 at risk EG0020 affected130 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA version 27.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected130 at risk EG0020 affected130 at risk
Electrocardiogram ST segment elevation	Investigations	MedDRA version 27.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected130 at risk EG0020 affected130 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG00016 affected132 at risk EG00120 affected130 at risk EG00225 affected130 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG00010 affected132 at risk EG00110 affected130 at risk EG0028 affected130 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0005 affected132 at risk EG0017 affected130 at risk EG0025 affected130 at risk
Constipation	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0002 affected132 at risk EG0018 affected130 at risk EG0027 affected130 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0007 affected132 at risk EG0015 affected130 at risk EG0028 affected130 at risk

First MCP Posted Date

ID	Term
C559645	12,13-dihydro-N-methyl-6,11,13-trioxo-5H-benzo(4,5)cyclohepta(1,2-b)naphthalen-5,12-imine
C121414	dai-kenchu-to

ParticipantsBG003392

ParticipantsBG003391

Units	Counts
Participants	OG000132 OG001128 OG002130

Units	Counts
Participants	OG000132 OG001128 OG002130

Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).

Placebo: Treatment with placebo product

Units	Counts
Participants	OG000132 OG001128 OG002130