Trial Outcomes & Findings for Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study (NCT NCT01766037)
NCT ID: NCT01766037
Last Updated: 2020-01-27
Results Overview
The first effectiveness co-primary endpoint is the mean percent excess weight loss (%EWL) at 52-weeks. The hypothesis for the first primary effectiveness endpoint is that the difference in the mean percent excess weight loss (%EWL) at 52-weeks for the Aspiration Therapy (AT) group and Control group is at least 10%. Percent EWL is defined as absolute weight loss divided by baseline excess weight and multiplied by 100. Excess weight is determined from ideal body weights based on a BMI=25 kg/m2.
COMPLETED
NA
171 participants
52 weeks
2020-01-27
Participant Flow
First Subject Screened Oct 30, 2012; First Subject Enrolled Nov 13, 2012; Last Subject Enrolled June 13, 2014
Participant milestones
| Measure |
Aspiration Therapy
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
60
|
|
Overall Study
COMPLETED
|
82
|
31
|
|
Overall Study
NOT COMPLETED
|
29
|
29
|
Reasons for withdrawal
| Measure |
Aspiration Therapy
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
10
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
18
|
16
|
|
Overall Study
Moved from area
|
5
|
0
|
|
Overall Study
medical - unrelated
|
1
|
2
|
|
Overall Study
nausea / discomfort
|
3
|
0
|
Baseline Characteristics
Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study
Baseline characteristics by cohort
| Measure |
Aspiration Therapy
n=111 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=60 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
111 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
43.9 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=5 Participants
|
60 participants
n=7 Participants
|
171 participants
n=5 Participants
|
|
Baseline Weight
|
116.9 Kilograms
STANDARD_DEVIATION 21.2 • n=5 Participants
|
112.8 Kilograms
STANDARD_DEVIATION 16.1 • n=7 Participants
|
115.4 Kilograms
STANDARD_DEVIATION 19.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Modified Intent To Treat (mITT) population defined as all enrolled subjects
The first effectiveness co-primary endpoint is the mean percent excess weight loss (%EWL) at 52-weeks. The hypothesis for the first primary effectiveness endpoint is that the difference in the mean percent excess weight loss (%EWL) at 52-weeks for the Aspiration Therapy (AT) group and Control group is at least 10%. Percent EWL is defined as absolute weight loss divided by baseline excess weight and multiplied by 100. Excess weight is determined from ideal body weights based on a BMI=25 kg/m2.
Outcome measures
| Measure |
Aspiration Therapy
n=111 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=60 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Mean Percent Excess Weight Loss (%EWL)
|
31.5 Percent Excess Weight Loss
Standard Deviation 26.7
|
9.8 Percent Excess Weight Loss
Standard Deviation 15.5
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Modified Intent To Treat (mITT) population of all enrolled subjects
The second co-primary effectiveness endpoint is that at least 50% of the AT group at 52-weeks achieve \> 25% EWL.
Outcome measures
| Measure |
Aspiration Therapy
n=111 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=60 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
% of Subjects Who Achieve >25% EWL
|
56.8 Percent of Subjects
Interval 49.0 to 64.5
|
22.0 Percent of Subjects
Interval 15.3 to 28.1
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Modified Intent To Treat (mITT) population of all enrolled subjects
i) Mean percent absolute weight loss in AT compared to Control group
Outcome measures
| Measure |
Aspiration Therapy
n=111 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=60 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Mean Percent Total Body Weight Loss
|
12.1 Percent Total Weight Loss
Standard Deviation 9.6
|
3.6 Percent Total Weight Loss
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Modified Intent To Treat (mITT) population of all enrolled subjects
ii) proportion of subjects who achieve ≥10% absolute weight loss in AT compared to Control group
Outcome measures
| Measure |
Aspiration Therapy
n=111 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=60 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Percent of Subjects With ≥10% Total Body Weight Loss
|
58.6 Percent of Subjects
Interval 50.3 to 66.6
|
11.9 Percent of Subjects
Interval 5.7 to 21.1
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Subjects who completed 52 weeks
iii) mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) in the AT group compared to the control group
Outcome measures
| Measure |
Aspiration Therapy
n=82 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=31 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Mean Percent Change in Serum Lipids
High Density Lipoprotein
|
8.1 Percent Change
Interval 4.2 to 12.0
|
1.7 Percent Change
Interval -3.8 to 7.2
|
|
Mean Percent Change in Serum Lipids
Low Density Lipoprotein
|
-4.2 Percent Change
Interval -8.5 to 0.1
|
-1.8 Percent Change
Interval -8.8 to 5.2
|
|
Mean Percent Change in Serum Lipids
Triglycerides
|
-9.9 Percent Change
Interval -17.7 to -2.0
|
0.1 Percent Change
Interval -15.9 to 16.1
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Subjects who completed 52 weeks
iv) mean percent change in systolic and diastolic blood pressures in the AT group compared to the control group
Outcome measures
| Measure |
Aspiration Therapy
n=82 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=31 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Mean Percent Change in Blood Pressure
Systolic Pressure
|
-1.2 Percent Change
Interval -4.0 to 1.5
|
-2.5 Percent Change
Interval -5.9 to 0.9
|
|
Mean Percent Change in Blood Pressure
Diastolic Pressure
|
-2.6 Percent Change
Interval -5.2 to 0.1
|
0.5 Percent Change
Interval -4.1 to 5.2
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Subjects who completed the Questionnaire at 52 weeks
v) "Impact of Weight on Quality of Life" (IWQOL) questionnaire total score Total score ranges from a minimum of 0 to a maximum of 100. Based on the algorithm developed by Crosby, et.al., patients' IWQOLLite total scores are considered to have shown meaningful improvement from baseline to one year if they increased between 7 and 12 points, depending upon baseline severity in comparison to the normative mean. Normative means for the IWQOL-Lite have been derived from a sample of 534 non-obese individuals who were not enrolled in any weight loss treatment program \[238 women and 296 men with BMI's between 18.5 and 29.9\]. The data presented is the mean change in total score. The AT group demonstrated a mean improvement (increase) in score of 16.3 points, the Control group a mean improvement (increase) of 11.7 points.
Outcome measures
| Measure |
Aspiration Therapy
n=81 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=27 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Mean Change in Score for IWQOL Questionnaire
|
16.3 score on a scale
Interval 12.5 to 20.1
|
11.7 score on a scale
Interval 5.5 to 17.9
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Subjects with Type 2 Diabetes
vi) change in mean hemoglobin A1C (only subjects with T2 diabetes at baseline). Hemoglobin A1C is measured as DCCT%. The change in mean DCCT% from Baseline to Week 52 is reported for this secondary endpoint.
Outcome measures
| Measure |
Aspiration Therapy
n=2 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=3 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Mean Change in Hemoglobin A1C
|
-2.3 DCCT% change
Interval -3.7 to -0.9
|
-0.37 DCCT% change
Interval -0.77 to -0.03
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All A-Tube placement attempts
vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy
Outcome measures
| Measure |
Aspiration Therapy
n=112 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Procedural Success
|
99 Percent Procedural Success
|
—
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Subjects being treated with medications for hypertension
Percent change in the number of medications taken by subjects for hypertension
Outcome measures
| Measure |
Aspiration Therapy
n=29 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=20 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Change in Medication for Hypertension
|
-53.5 Percent Change in Medications
|
-9.4 Percent Change in Medications
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Subjects being treated for high cholesterol
Percent change in the number of medications taken by subjects for dyslipidemia
Outcome measures
| Measure |
Aspiration Therapy
n=13 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=12 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Change in Medications for Dyslipidemia
|
-23.1 Percent Change in Medications
|
-7.7 Percent Change in Medications
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Subjects being treated for Type 2 Diabetes
Percent change in the number of medications taken by subjects for Type 2 Diabetes
Outcome measures
| Measure |
Aspiration Therapy
n=3 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=6 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Change in Medications for Type 2 Diabetes
|
-33.0 Percent Change in Medications
|
-14.3 Percent Change in Medications
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Subjects being treated for hypertension
Percent change in the number of subjects on Hypertension medication
Outcome measures
| Measure |
Aspiration Therapy
n=29 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=20 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Change in Number of Subjects on Hypertension Medication
|
-62.1 % Change in Subjects on Medication
|
-10.0 % Change in Subjects on Medication
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Subjects being treated for high cholesterol
Percent change in the number of subjects on Dyslipidemia medications
Outcome measures
| Measure |
Aspiration Therapy
n=13 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=12 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Change in Number of Subjects on Dyslipidemia Medications
|
-23.1 % Change in Subjects on Medication
|
-8.3 % Change in Subjects on Medication
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Subjects being treated for Type II Diabetes
Percent change in the number of subjects on Diabetes medication
Outcome measures
| Measure |
Aspiration Therapy
n=3 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=6 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Change in Number of Subjects on Diabetes Medication
|
-33.3 % Change in Subjects on Medication
|
-16.7 % Change in Subjects on Medication
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 52 weeksPopulation: Modified Intent To Treat (mITT) population of all enrolled subjects
The incidence of procedure-related, device-related, and therapy-related serious adverse events. Also, the development of adverse eating behaviors will be assessed.
Outcome measures
| Measure |
Aspiration Therapy
n=111 Participants
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=60 Participants
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Safety Outcomes
Serious Adverse Event
|
3.6 Percent of Subjects
|
0 Percent of Subjects
|
|
Safety Outcomes
Diagnosed Eating Disorder
|
0 Percent of Subjects
|
1.7 Percent of Subjects
|
Adverse Events
Aspiration Therapy
Lifestyle Therapy
Serious adverse events
| Measure |
Aspiration Therapy
n=111 participants at risk
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=60 participants at risk
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Surgical and medical procedures
Peritonitis
|
0.90%
1/111 • Number of events 1 • 52 weeks
|
0.00%
0/60 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.90%
1/111 • Number of events 2 • 52 weeks
|
0.00%
0/60 • 52 weeks
|
|
Gastrointestinal disorders
Prepyloric Ulceration
|
0.90%
1/111 • Number of events 1 • 52 weeks
|
0.00%
0/60 • 52 weeks
|
|
Surgical and medical procedures
A-Tube Replacement
|
0.90%
1/111 • Number of events 1 • 52 weeks
|
0.00%
0/60 • 52 weeks
|
Other adverse events
| Measure |
Aspiration Therapy
n=111 participants at risk
Aspiration Therapy and Lifestyle Therapy
Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
Lifestyle Therapy
n=60 participants at risk
Lifestyle Therapy only
Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Granulation Tissue
|
40.5%
45/111 • Number of events 45 • 52 weeks
|
0.00%
0/60 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal Pain (post procedure)
|
37.8%
42/111 • Number of events 42 • 52 weeks
|
0.00%
0/60 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Peristomal Discharge
|
30.6%
34/111 • Number of events 34 • 52 weeks
|
0.00%
0/60 • 52 weeks
|
|
Gastrointestinal disorders
Nausea / Vomiting
|
18.9%
21/111 • Number of events 21 • 52 weeks
|
0.00%
0/60 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
18.9%
21/111 • Number of events 21 • 52 weeks
|
0.00%
0/60 • 52 weeks
|
|
Infections and infestations
Peristomal Infection
|
14.4%
16/111 • Number of events 16 • 52 weeks
|
0.00%
0/60 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal Pain (after 4 weeks)
|
8.1%
9/111 • Number of events 9 • 52 weeks
|
0.00%
0/60 • 52 weeks
|
|
Gastrointestinal disorders
Change in Bowel Habits
|
4.5%
5/111 • Number of events 5 • 52 weeks
|
0.00%
0/60 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place