Trial Outcomes & Findings for Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery in Subjects Undergoing Bowel Resection (NCT NCT04742907)
NCT ID: NCT04742907
Last Updated: 2025-04-16
Results Overview
Time to achieve recovery of GI motility as measured by a composite endpoint representing upper AND lower GI recovery
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
402 participants
Primary outcome timeframe
From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)
Results posted on
2025-04-16
Participant Flow
The study was carried out at 36 sites in the United States (US).
Participant milestones
| Measure |
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
|
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
|
Placebo
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
Overall Study
STARTED
|
134
|
134
|
134
|
|
Overall Study
Safety (Baseline) Analysis Set
|
132
|
130
|
130
|
|
Overall Study
COMPLETED
|
120
|
114
|
120
|
|
Overall Study
NOT COMPLETED
|
14
|
20
|
14
|
Reasons for withdrawal
| Measure |
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
|
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
|
Placebo
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
4
|
|
Overall Study
Subject Refusal of Study Procedures or Unable to Take the Study Drug
|
2
|
5
|
2
|
|
Overall Study
Did Not Receive the Study Drug
|
2
|
4
|
4
|
Baseline Characteristics
One subject in 7.5 g/day is excluded from the BMI calculation due to missing height.
Baseline characteristics by cohort
| Measure |
TU-100 15 g/Day
n=132 Participants
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
|
TU-100 7.5 g/Day
n=130 Participants
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
|
Placebo
n=130 Participants
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
Total
n=392 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 13.14 • n=132 Participants
|
58.3 years
STANDARD_DEVIATION 13.07 • n=130 Participants
|
58.5 years
STANDARD_DEVIATION 12.09 • n=130 Participants
|
58.2 years
STANDARD_DEVIATION 12.75 • n=392 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=132 Participants
|
69 Participants
n=130 Participants
|
72 Participants
n=130 Participants
|
209 Participants
n=392 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=132 Participants
|
61 Participants
n=130 Participants
|
58 Participants
n=130 Participants
|
183 Participants
n=392 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=132 Participants
|
9 Participants
n=130 Participants
|
13 Participants
n=130 Participants
|
27 Participants
n=392 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
125 Participants
n=132 Participants
|
121 Participants
n=130 Participants
|
116 Participants
n=130 Participants
|
362 Participants
n=392 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
1 Participants
n=130 Participants
|
3 Participants
n=392 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=392 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=132 Participants
|
1 Participants
n=130 Participants
|
3 Participants
n=130 Participants
|
10 Participants
n=392 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=392 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=132 Participants
|
6 Participants
n=130 Participants
|
10 Participants
n=130 Participants
|
29 Participants
n=392 Participants
|
|
Race (NIH/OMB)
White
|
109 Participants
n=132 Participants
|
118 Participants
n=130 Participants
|
110 Participants
n=130 Participants
|
337 Participants
n=392 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=132 Participants
|
1 Participants
n=130 Participants
|
0 Participants
n=130 Participants
|
1 Participants
n=392 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=132 Participants
|
4 Participants
n=130 Participants
|
7 Participants
n=130 Participants
|
15 Participants
n=392 Participants
|
|
BMI
|
28.43 kg/m2
STANDARD_DEVIATION 6.242 • n=132 Participants • One subject in 7.5 g/day is excluded from the BMI calculation due to missing height.
|
29.46 kg/m2
STANDARD_DEVIATION 5.788 • n=129 Participants • One subject in 7.5 g/day is excluded from the BMI calculation due to missing height.
|
28.97 kg/m2
STANDARD_DEVIATION 5.649 • n=130 Participants • One subject in 7.5 g/day is excluded from the BMI calculation due to missing height.
|
28.95 kg/m2
STANDARD_DEVIATION 5.900 • n=391 Participants • One subject in 7.5 g/day is excluded from the BMI calculation due to missing height.
|
PRIMARY outcome
Timeframe: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)Population: 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.
Time to achieve recovery of GI motility as measured by a composite endpoint representing upper AND lower GI recovery
Outcome measures
| Measure |
TU-100 15 g/Day
n=132 Participants
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
|
TU-100 7.5 g/Day
n=128 Participants
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
|
Placebo
n=130 Participants
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
Time to Gastrointestinal Recovery (GIR)
|
32.6 hours
Interval 29.7 to 41.2
|
30.8 hours
Interval 28.1 to 35.3
|
33.4 hours
Interval 29.1 to 40.9
|
SECONDARY outcome
Timeframe: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)Population: 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.
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
Outcome measures
| Measure |
TU-100 15 g/Day
n=132 Participants
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
|
TU-100 7.5 g/Day
n=128 Participants
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
|
Placebo
n=130 Participants
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
Time to GIR Responses
Median Time to GI-2
|
49.4 hours
Interval 44.8 to 57.6
|
45.2 hours
Interval 43.5 to 46.8
|
47.2 hours
Interval 41.9 to 50.2
|
|
Time to GIR Responses
Median Time to absence of distension and presence of bowel sounds and flatus
|
38.2 hours
Interval 31.3 to 41.8
|
40.1 hours
Interval 30.7 to 43.7
|
41.2 hours
Interval 37.8 to 44.6
|
|
Time to GIR Responses
Median Time to first toleration of clear liquids
|
24.0 hours
Interval 22.6 to 25.5
|
22.5 hours
Interval 21.2 to 23.6
|
23.3 hours
Interval 22.6 to 24.9
|
SECONDARY outcome
Timeframe: From surgery to hospital dischargePopulation: 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.
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)
Outcome measures
| Measure |
TU-100 15 g/Day
n=132 Participants
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
|
TU-100 7.5 g/Day
n=128 Participants
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
|
Placebo
n=130 Participants
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
Time to Discharge
Time to ready for discharge
|
56.1 hours
Interval 49.4 to 66.3
|
52.2 hours
Interval 48.4 to 59.8
|
66.1 hours
Interval 52.4 to 68.2
|
|
Time to Discharge
Time to discharge order written
|
64.3 hours
Interval 50.5 to 67.8
|
58.1 hours
Interval 51.1 to 65.7
|
66.6 hours
Interval 63.5 to 69.1
|
SECONDARY outcome
Timeframe: From surgery to hospital dischargePopulation: 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.
Mean number of days that the subject stayed in the hospital calculated based on calendar day of discharge order written
Outcome measures
| Measure |
TU-100 15 g/Day
n=132 Participants
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
|
TU-100 7.5 g/Day
n=128 Participants
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
|
Placebo
n=130 Participants
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
GIR Outcome Related to Length of Hospitalization (Mean)
|
3.3 days
Standard Deviation 3.07
|
2.7 days
Standard Deviation 1.30
|
3.3 days
Standard Deviation 3.00
|
SECONDARY outcome
Timeframe: From surgery to hospital dischargePopulation: 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.
Median number of days that the subject stayed in the hospital calculated based on calendar day of discharge order written
Outcome measures
| Measure |
TU-100 15 g/Day
n=132 Participants
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
|
TU-100 7.5 g/Day
n=128 Participants
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
|
Placebo
n=130 Participants
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
GIR Outcome Related to Length of Hospitalization (Median)
|
3 days
Interval 1.0 to 28.0
|
2 days
Interval 1.0 to 7.0
|
3 days
Interval 1.0 to 29.0
|
SECONDARY outcome
Timeframe: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)Population: 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.
Percentage of subjects who achieve GIR (GIR responders) by day
Outcome measures
| Measure |
TU-100 15 g/Day
n=132 Participants
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
|
TU-100 7.5 g/Day
n=128 Participants
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
|
Placebo
n=130 Participants
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
Percentage of GIR Responders
Day 1
|
20.5 percentage of subjects
|
22.7 percentage of subjects
|
24.6 percentage of subjects
|
|
Percentage of GIR Responders
Day 2
|
47.0 percentage of subjects
|
55.5 percentage of subjects
|
42.3 percentage of subjects
|
|
Percentage of GIR Responders
Day 3
|
18.2 percentage of subjects
|
14.1 percentage of subjects
|
20.8 percentage of subjects
|
|
Percentage of GIR Responders
Day 4
|
3.8 percentage of subjects
|
1.6 percentage of subjects
|
6.2 percentage of subjects
|
SECONDARY outcome
Timeframe: From the day after surgery to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)Population: 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.
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)
Outcome measures
| Measure |
TU-100 15 g/Day
n=132 Participants
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
|
TU-100 7.5 g/Day
n=128 Participants
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
|
Placebo
n=130 Participants
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
POI-related Morbidity
|
7 Participants
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)Population: 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.
Number of patients with adverse events (AEs) observed following administration of TU-100.
Outcome measures
| Measure |
TU-100 15 g/Day
n=132 Participants
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
|
TU-100 7.5 g/Day
n=128 Participants
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
|
Placebo
n=130 Participants
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
78 Participants
|
73 Participants
|
81 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)Population: 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.
Subjects will record the occurrence of nausea in their eDiaries on all postoperative in-hospital days.
Outcome measures
| Measure |
TU-100 15 g/Day
n=104 Participants
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
|
TU-100 7.5 g/Day
n=101 Participants
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
|
Placebo
n=103 Participants
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
Subject-Reported Occurrence of Nausea
Day 2
|
26 Participants
|
16 Participants
|
25 Participants
|
|
Subject-Reported Occurrence of Nausea
Day 3
|
10 Participants
|
9 Participants
|
11 Participants
|
|
Subject-Reported Occurrence of Nausea
Day 1
|
39 Participants
|
37 Participants
|
35 Participants
|
|
Subject-Reported Occurrence of Nausea
Day 4
|
3 Participants
|
6 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)Population: 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.
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.
Outcome measures
| Measure |
TU-100 15 g/Day
n=40 Participants
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
|
TU-100 7.5 g/Day
n=38 Participants
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
|
Placebo
n=35 Participants
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
Subject-Reported Bothersomeness of Nausea
Day 1
|
5.5 score of nausea bothersomeness
Standard Error 0.46
|
6.0 score of nausea bothersomeness
Standard Error 0.47
|
6.1 score of nausea bothersomeness
Standard Error 0.48
|
|
Subject-Reported Bothersomeness of Nausea
Day 2
|
6.0 score of nausea bothersomeness
Standard Error 0.53
|
4.7 score of nausea bothersomeness
Standard Error 0.66
|
5.8 score of nausea bothersomeness
Standard Error 0.54
|
|
Subject-Reported Bothersomeness of Nausea
Day 3
|
6.7 score of nausea bothersomeness
Standard Error 0.78
|
5.5 score of nausea bothersomeness
Standard Error 0.86
|
6.5 score of nausea bothersomeness
Standard Error 0.79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)Population: 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.
Subjects will record the occurrence of abdominal bloating in their eDiaries on all postoperative in-hospital days.
Outcome measures
| Measure |
TU-100 15 g/Day
n=104 Participants
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
|
TU-100 7.5 g/Day
n=101 Participants
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
|
Placebo
n=103 Participants
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
Subject-Reported Occurrence of Abdominal Bloating
Day 1
|
61 Participants
|
67 Participants
|
66 Participants
|
|
Subject-Reported Occurrence of Abdominal Bloating
Day 2
|
30 Participants
|
30 Participants
|
49 Participants
|
|
Subject-Reported Occurrence of Abdominal Bloating
Day 3
|
14 Participants
|
13 Participants
|
21 Participants
|
|
Subject-Reported Occurrence of Abdominal Bloating
Day 4
|
6 Participants
|
7 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the day after surgery (Day 1) until hospital discharge or Day 10 (whichever is earlier)Population: 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.
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.
Outcome measures
| Measure |
TU-100 15 g/Day
n=62 Participants
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
|
TU-100 7.5 g/Day
n=67 Participants
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
|
Placebo
n=66 Participants
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
Subject-Reported Bothersomeness of Abdominal Bloating
Day 1
|
5.2 score of bloating bothersomeness
Standard Error 0.34
|
4.2 score of bloating bothersomeness
Standard Error 0.33
|
5.2 score of bloating bothersomeness
Standard Error 0.33
|
|
Subject-Reported Bothersomeness of Abdominal Bloating
Day 2
|
5.6 score of bloating bothersomeness
Standard Error 0.44
|
4.4 score of bloating bothersomeness
Standard Error 0.43
|
4.6 score of bloating bothersomeness
Standard Error 0.36
|
|
Subject-Reported Bothersomeness of Abdominal Bloating
Day 3
|
5.6 score of bloating bothersomeness
Standard Error 0.62
|
4.3 score of bloating bothersomeness
Standard Error 0.64
|
5.0 score of bloating bothersomeness
Standard Error 0.51
|
Adverse Events
TU-100 15 g/Day
Serious events: 19 serious events
Other events: 29 other events
Deaths: 0 deaths
TU-100 7.5 g/Day
Serious events: 14 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo
Serious events: 9 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TU-100 15 g/Day
n=132 participants at risk
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
|
TU-100 7.5 g/Day
n=130 participants at risk
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
|
Placebo
n=130 participants at risk
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
6.1%
8/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
2.3%
3/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
2.3%
3/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.00%
0/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.5%
2/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Infections and infestations
Perirectal abscess
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
1.5%
2/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal mucosal tear
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
1.5%
2/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.76%
1/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.77%
1/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
0.00%
0/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
Other adverse events
| Measure |
TU-100 15 g/Day
n=132 participants at risk
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
|
TU-100 7.5 g/Day
n=130 participants at risk
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
|
Placebo
n=130 participants at risk
Subjects will receive placebo TID until hospital discharge or ≤ 10 days (whichever is earlier).
Placebo: Treatment with placebo product
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.1%
16/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
15.4%
20/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
19.2%
25/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
7.6%
10/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
7.7%
10/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
6.2%
8/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.8%
5/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
5.4%
7/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
3.8%
5/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
1.5%
2/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
6.2%
8/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
5.4%
7/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
7/132 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
3.8%
5/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
6.2%
8/130 • From baseline to discharge follow-up visit (30 days (+ 15 days) after hospital discharge)
Adverse Events reported in all randomized subjects who receive at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place